Trial Outcomes & Findings for Oscillation and Lung Expansion (OLE) Therapy for Treatment of Neuromuscular Disease (NMD) Patients (NCT NCT05366010)
NCT ID: NCT05366010
Last Updated: 2025-07-31
Results Overview
Exacerbation of pulmonary disease is a worsening of pulmonary condition or an event requiring one or more of the following: * Hospitalization * Emergency Department visit * Unscheduled antibiotics * Unscheduled outpatient visit
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
6 months pre-treatment and 6 months post-treatment with the Volara System
Results posted on
2025-07-31
Participant Flow
Retrospective data was collected from a total of 41 patients. Two patients died prior to study start. Thus, these two patients were excluded from any safety analyses as they had no exposure to the Volara System.
Participant milestones
| Measure |
Intervention
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Intervention
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Screen Failure
|
2
|
Baseline Characteristics
Oscillation and Lung Expansion (OLE) Therapy for Treatment of Neuromuscular Disease (NMD) Patients
Baseline characteristics by cohort
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Age, Continuous
|
19.4 years
STANDARD_DEVIATION 15.94 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 months pre-treatment and 6 months post-treatment with the Volara SystemExacerbation of pulmonary disease is a worsening of pulmonary condition or an event requiring one or more of the following: * Hospitalization * Emergency Department visit * Unscheduled antibiotics * Unscheduled outpatient visit
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention
6 months pre-treatment
|
1.0 Exacerbations
Standard Deviation 0.81
|
|
Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention
Volara active treatment
|
1.2 Exacerbations
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline and monthly for 6 monthsPopulation: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 12 subjects had data available for Slow Vital Capacity. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
Slow Vital Capacity is the maximum volume that the subject can exhale in a single breath, following full inspiration. The measure is taken using a slow consistent exhalation.
Outcome measures
| Measure |
Intervention
n=12 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Slow Vital Capacity
Baseline
|
1.523 Litres
Standard Deviation 0.7664
|
|
Slow Vital Capacity
1 month
|
1.609 Litres
Standard Deviation 0.6891
|
|
Slow Vital Capacity
2 months
|
1.693 Litres
Standard Deviation 0.6684
|
|
Slow Vital Capacity
3 months
|
1.741 Litres
Standard Deviation 0.6763
|
|
Slow Vital Capacity
4 months
|
1.407 Litres
Standard Deviation 0.6580
|
|
Slow Vital Capacity
5 months
|
1.498 Litres
Standard Deviation 0.5858
|
|
Slow Vital Capacity
6 months
|
1.601 Litres
Standard Deviation 0.4604
|
SECONDARY outcome
Timeframe: Baseline and monthly for 6 monthsPopulation: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 10 subjects had data available for Peak Cough Flow. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
Peak Cough Flow is a pulmonary function measure that evaluates maximum peak flow generated during a cough maneuver. It will be measured with a hand-held spirometer.
Outcome measures
| Measure |
Intervention
n=10 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Peak Cough Flow
Baseline
|
2.121 Litres per second
Standard Deviation 1.4399
|
|
Peak Cough Flow
1 month
|
2.730 Litres per second
Standard Deviation 1.3391
|
|
Peak Cough Flow
2 months
|
2.595 Litres per second
Standard Deviation 0.0778
|
|
Peak Cough Flow
3 months
|
2.874 Litres per second
Standard Deviation 0.6911
|
|
Peak Cough Flow
4 months
|
3.297 Litres per second
Standard Deviation 0.5543
|
|
Peak Cough Flow
5 months
|
3.327 Litres per second
Standard Deviation 0.9673
|
|
Peak Cough Flow
6 months
|
2.153 Litres per second
Standard Deviation 1.6887
|
SECONDARY outcome
Timeframe: Baseline and monthly for 6 monthsPopulation: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 22 subjects had data available for Resting Oxygen Saturation. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter.
Outcome measures
| Measure |
Intervention
n=22 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Resting Oxygen Saturation
Baseline
|
95.68 percentage oxygen saturation
Standard Deviation 1.978
|
|
Resting Oxygen Saturation
1 month
|
96.78 percentage oxygen saturation
Standard Deviation 1.986
|
|
Resting Oxygen Saturation
2 months
|
96.57 percentage oxygen saturation
Standard Deviation 2.699
|
|
Resting Oxygen Saturation
3 months
|
96.73 percentage oxygen saturation
Standard Deviation 1.794
|
|
Resting Oxygen Saturation
4 months
|
96.11 percentage oxygen saturation
Standard Deviation 2.759
|
|
Resting Oxygen Saturation
5 months
|
97.00 percentage oxygen saturation
Standard Deviation 2.000
|
|
Resting Oxygen Saturation
6 months
|
95.64 percentage oxygen saturation
Standard Deviation 3.641
|
SECONDARY outcome
Timeframe: Baseline and monthly for 6 monthsPopulation: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 11 subjects had data available for Maximal Inspiratory Pressure. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
Maximal Inspiratory Pressure is the maximum force (measured in centimeters of water \[cmH2O\]) that the subject can generate during an inspiratory effort.
Outcome measures
| Measure |
Intervention
n=11 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Maximal Inspiratory Pressure
Baseline
|
-40.7 centimeters of water
Standard Deviation 16.56
|
|
Maximal Inspiratory Pressure
1 month
|
-45.7 centimeters of water
Standard Deviation 16.18
|
|
Maximal Inspiratory Pressure
2 months
|
-46.3 centimeters of water
Standard Deviation 17.86
|
|
Maximal Inspiratory Pressure
3 months
|
-48.6 centimeters of water
Standard Deviation 16.81
|
|
Maximal Inspiratory Pressure
4 months
|
-42.3 centimeters of water
Standard Deviation 18.29
|
|
Maximal Inspiratory Pressure
5 months
|
-42.8 centimeters of water
Standard Deviation 21.91
|
|
Maximal Inspiratory Pressure
6 months
|
-50.8 centimeters of water
Standard Deviation 12.81
|
SECONDARY outcome
Timeframe: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara SystemNumber of hospital admissions for respiratory complications.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Number of Hospital Admissions
6 months pre-treatment
|
0.5 number of visits
Standard Deviation 0.67
|
|
Number of Hospital Admissions
Volara active treatment
|
0.4 number of visits
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara SystemNumber of inpatient hospital days for respiratory complications
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Total Hospital Length of Stay
6 months pre-treatment
|
5.2 days
Standard Deviation 7.90
|
|
Total Hospital Length of Stay
Volara active treatment
|
1.7 days
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara SystemNumber of ICU admissions for respiratory complications.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Number of Intensive Care Unit (ICU) Admissions
6 months pre-treatment
|
0.2 Number of visits
Standard Deviation 0.55
|
|
Number of Intensive Care Unit (ICU) Admissions
Volara active treatment
|
0.2 Number of visits
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara SystemNumber of ICU hospital days for respiratory complications
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Total Intensive Care Unit (ICU) Length of Stay
6 months pre-treatment
|
1.9 days
Standard Deviation 5.42
|
|
Total Intensive Care Unit (ICU) Length of Stay
Volara active treatment
|
0.8 days
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: 6 months pre-treatment and 6 months post-treatment with the Volara SystemNumber of unscheduled Physician's office visits, urgent care visits, and emergency department (ED) visits.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Number of Outpatient Visits for Pulmonary Complications
6 months pre-treatment
|
0.7 Number of visits
Standard Deviation 0.82
|
|
Number of Outpatient Visits for Pulmonary Complications
Volara active treatment
|
0.9 Number of visits
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 6 months pre-treatment and 6 months post-treatment with the Volara SystemThe total number of antibiotic use days includes any of the following: intravenous (IV) antibiotic days, oral antibiotic days, and nebulized antibiotic days.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Total Number of Antibiotic Use Days During Episodes for Respiratory Infection
6 months pre-treatment
|
6.6 Number of days
Standard Deviation 8.04
|
|
Total Number of Antibiotic Use Days During Episodes for Respiratory Infection
Volara active treatment
|
4.5 Number of days
Standard Deviation 7.57
|
SECONDARY outcome
Timeframe: Total number of days the subject had the device (approximately up to 6 months of OLE therapy)Population: Device usage information was only available for 18 of the 33 subjects as the remaining subjects did not return the Volara System. Some subjects retained the device beyond the 6-month active treatment period.
Adherence to the OLE treatment regimen was presented as Average Daily Volara System Usage. This was calculated by dividing the total minutes of device use by the total number of days the subject had the device.
Outcome measures
| Measure |
Intervention
n=18 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Adherence to Treatment Regimen: Average Daily Volara System Usage
|
15.1 minutes/day
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Baseline, and after 1 month, 3 months, and 6 months of therapy using the Volara SystemPopulation: All responses obtained are presented. Some patients did not provide feedback at certain follow-up visits.
Severe Respiratory Insufficiency (SRI) questionnaire administered at baseline, and at 1, 3 and 6 months. The total score can range from a minimum of 0 to a maximum of 100 with higher values indicating a better health-related quality of life according to content of the scale.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire
Baseline
|
45.654 Score on SRI scale
Standard Deviation 22.6888
|
|
Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire
1 month
|
57.000 Score on SRI scale
Standard Deviation 21.0432
|
|
Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire
3 months
|
59.953 Score on SRI scale
Standard Deviation 22.4735
|
|
Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire
6 months
|
63.390 Score on SRI scale
Standard Deviation 21.2530
|
SECONDARY outcome
Timeframe: BaselineSatisfaction is assessed through a questionnaire administered at baseline. Seven satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 35, with 35 indicating the highest satisfaction.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q1R1. It is so difficult to use the current airway clearance therapy that I do not want to use it
|
0 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q1R2. It is very difficult to use the current airway clearance therapy
|
0 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q1R3. It is moderately difficult to use the current airway clearance therapy
|
7 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q1R4. It is fairly easy to use the current airway clearance therapy
|
14 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q1R5. It is very easy to use the current airway clearance therapy
|
5 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q1R0. No answer on ease/difficulty of using the current airway clearance therapy
|
7 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q2R1. It is so difficult to tolerate the current airway clearance therapy that I don't want to do it
|
0 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q2R2. It is very difficult to tolerate the current airway clearance therapy
|
1 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q2R3. It is moderately difficult to tolerate the current airway clearance therapy
|
6 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q2R4. It is fairly easy to tolerate the current airway clearance therapy
|
12 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q2R5. It is very easy to tolerate the current airway clearance therapy
|
6 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q2R0. No answer on ease/difficulty of tolerating the current airway clearance therapy
|
8 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q3R1. I never miss therapy with the current airway clearance therapy
|
12 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q3R2. I miss therapy once a week
|
7 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q3R3. I miss therapy twice a week
|
2 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q3R4. I miss therapy three times a week
|
3 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q3R5. I miss therapy four or more times a week
|
1 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q3R0. No response on frequency of missing therapy per week
|
8 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q4R1. The current airway clearance is not effective as I never bring up sputum with therapy
|
2 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q4R2. The current airway clearance therapy is effective sometimes
|
11 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q4R3. The current airway clearance therapy is mostly effective
|
6 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q4R4. The current airway clearance therapy is almost always effective
|
5 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q4R5. I always bring up sputum with therapy
|
2 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q4R0. No answer on effectiveness of current airway clearance therapy on bringing up sputum
|
7 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q5R1. I always feel short of breath
|
0 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q5R2. I frequently have shortness of breath episodes
|
2 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q5R3. I have some shortness of breath episodes
|
5 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q5R4. I have a few shortness of breath episodes
|
15 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q5R5. I never have shortness of breath
|
3 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q5R0. No answer on effect of current airway clearance therapy on breathing
|
8 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q6R1. I do not feel the current airway clearance therapy helps my lungs stay healthy
|
1 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q6R2. I am unsure if this therapy helps my lungs stay healthy
|
0 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q6R3. This therapy seems somewhat helpful helpful for my lungs
|
10 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q6R4. I feel this therapy helps my lungs stay healthy
|
10 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q6R5. I definitely feel this therapy helps my lungs stay healthy
|
4 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q6R0. No answer on whether patients feel the current therapy helps their lungs feel healthy
|
8 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q7R1. My ability to perform daily tasks has definitely not improved
|
1 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q7R2. My ability to perform daily tasks has not improved
|
2 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q7R3. I am unsure if my ability to perform daily tasks has improved
|
8 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q7R4. I have had some improvement in ability to perform daily tasks
|
13 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q7R5. I have had significant improvement in ability to perform daily tasks
|
1 Participants
|
|
Satisfaction With Current Airway Clearance Therapy at Baseline
Q7R0. No answer on effect of current therapy on ability to perform daily tasks
|
8 Participants
|
SECONDARY outcome
Timeframe: After 1 month of using the Volara SystemSatisfaction is assessed through a questionnaire administered after 1 month of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q8R4. I prefer to continue to do therapy with the Volara System
|
17 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q8R5. I strongly prefer to continue to do therapy with the Volara System
|
9 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q8R0. No answer given on therapy preference
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q1R1. It is so difficult to use the Volara System that I do not want to use it
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q1R2. It is very difficult to use the Volara System
|
1 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q1R3. It is moderately difficult to use the Volara System
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q1R4. It is fairly easy to use the Volara System
|
15 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q1R5. It is very easy to use the Volara System
|
15 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q1R0. No answer on ease/difficulty of using the Volara System
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q2R2. It is very difficult to tolerate therapy with the Volara System
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q2R3. It is moderately difficult to tolerate therapy with the Volara System
|
3 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q2R4. It is fairly easy to tolerate therapy with the Volara System
|
17 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q2R5. It is very easy to tolerate therapy with the Volara System
|
9 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q3R1. I never miss therapy
|
17 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q3R2. I miss therapy once a week
|
8 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q3R3. I miss therapy twice a week
|
1 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q3R4. I miss therapy three times a week
|
4 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q3R5. I miss therapy four or more times a week
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q3R0. No response on frequency of missing therapy per week
|
3 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q4R1. The therapy is not effective as I never bring up sputum with therapy
|
3 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q4R2. The therapy is effective sometimes
|
8 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q4R3. The therapy is mostly effective
|
11 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q4R4. The therapy is almost always effective
|
6 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q4R5. I always bring up sputum with therapy
|
3 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q4R0. No answer on effectiveness of therapy in bringing up sputum
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q5R1. I always feel short of breath
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q5R2. I frequently have shortness of breath episodes
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q5R3. I have some shortness of breath episodes
|
7 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q5R4. I have a few shortness of breath episodes
|
19 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q5R5. I never have shortness of breath
|
5 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q5R0. No answer on effect of therapy on breathing
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q6R1. I do not feel the therapy helps my lungs stay healthy
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q6R2. I am unsure if this therapy helps my lungs stay healthy
|
3 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q6R3. This therapy seems somewhat helpful helpful for my lungs
|
7 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q6R4. I feel this therapy helps my lungs stay healthy
|
15 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q6R5. I definitely feel this therapy helps my lungs stay healthy
|
5 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy
|
3 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q7R1. My ability to perform daily tasks has definitely not improved
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q7R2. My ability to perform daily tasks has not improved
|
3 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q7R3. I am unsure if my ability to perform daily tasks has improved
|
14 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q7R4. I have had some improvement in ability to perform daily tasks
|
10 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q7R5. I have had significant improvement in ability to perform daily tasks
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q7R0. No answer on effect of current therapy on ability to perform daily tasks
|
4 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q8R1. I do not want to continue. I strongly prefer to use my previous therapy
|
0 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q8R2. I prefer to use my previous therapy
|
2 Participants
|
|
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Q8R3. I do not have a preference on which therapy I use
|
3 Participants
|
SECONDARY outcome
Timeframe: After 3 months of using the Volara SystemSatisfaction is assessed through a questionnaire administered after 3 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q1R1. It is so difficult to use the Volara System that I do not want to use it
|
0 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q1R2. It is very difficult to use the Volara System
|
0 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q1R3. It is moderately difficult to use the Volara System
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q1R4. It is fairly easy to use the Volara System
|
15 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q1R5. It is very easy to use the Volara System
|
13 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q1R0. No answer on ease/difficulty of using the Volara System
|
4 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it
|
0 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q2R2. It is very difficult to tolerate therapy with the Volara System
|
0 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q2R3. It is moderately difficult to tolerate therapy with the Volara System
|
4 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q2R4. It is fairly easy to tolerate therapy with the Volara System
|
15 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q2R5. It is very easy to tolerate therapy with the Volara System
|
10 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System
|
4 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q3R1. I never miss therapy
|
14 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q3R2. I miss therapy once a week
|
12 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q3R3. I miss therapy twice a week
|
2 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q3R4. I miss therapy three times a week
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q3R5. I miss therapy four or more times a week
|
0 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q3R0. No response on frequency of missing therapy per week
|
4 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q4R1. The therapy is not effective as I never bring up sputum with therapy
|
2 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q4R2. The therapy is effective sometimes
|
9 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q4R3. The therapy is mostly effective
|
5 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q4R4. The therapy is almost always effective
|
9 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q4R5. I always bring up sputum with therapy
|
4 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q4R0. No answer on effectiveness of therapy in bringing up sputum
|
4 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q5R1. I always feel short of breath
|
0 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q5R2. I frequently have shortness of breath episodes
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q5R3. I have some shortness of breath episodes
|
3 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q5R4. I have a few shortness of breath episodes
|
14 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q5R5. I never have shortness of breath
|
10 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q5R0. No answer on effect of therapy on breathing
|
5 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q6R1. I do not feel the therapy helps my lungs stay healthy
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q6R2. I am unsure if this therapy helps my lungs stay healthy
|
2 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q6R3. This therapy seems somewhat helpful helpful for my lungs
|
7 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q6R4. I feel this therapy helps my lungs stay healthy
|
12 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q6R5. I definitely feel this therapy helps my lungs stay healthy
|
7 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy
|
4 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q7R1. My ability to perform daily tasks has definitely not improved
|
0 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q7R2. My ability to perform daily tasks has not improved
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q7R3. I am unsure if my ability to perform daily tasks has improved
|
12 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q7R4. I have had some improvement in ability to perform daily tasks
|
11 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q7R5. I have had significant improvement in ability to perform daily tasks
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q7R0. No answer on effect of current therapy on ability to perform daily tasks
|
8 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q8R1. I do not want to continue. I strongly prefer to use my previous therapy
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q8R2. I prefer to use my previous therapy
|
1 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q8R3. I do not have a preference on which therapy I use
|
5 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q8R4. I prefer to continue to do therapy with the Volara System
|
14 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q8R5. I strongly prefer to continue to do therapy with the Volara System
|
8 Participants
|
|
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Q8R0. No answer given on therapy preference
|
4 Participants
|
SECONDARY outcome
Timeframe: After 6 months of using the Volara SystemSatisfaction is assessed through a questionnaire administered after 6 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Outcome measures
| Measure |
Intervention
n=33 Participants
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q8R2. I prefer to use my previous therapy
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q1R1. It is so difficult to use the Volara System that I do not want to use it
|
0 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q1R2. It is very difficult to use the Volara System
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q1R3. It is moderately difficult to use the Volara System
|
1 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q1R4. It is fairly easy to use the Volara System
|
13 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q1R5. It is very easy to use the Volara System
|
11 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q1R0. No answer on ease/difficulty of using the Volara System
|
6 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it
|
1 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q2R2. It is very difficult to tolerate therapy with the Volara System
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q2R3. It is moderately difficult to tolerate therapy with the Volara System
|
3 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q2R4. It is fairly easy to tolerate therapy with the Volara System
|
14 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q2R5. It is very easy to tolerate therapy with the Volara System
|
7 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System
|
6 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q3R1. I never miss therapy
|
13 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q3R2. I miss therapy once a week
|
7 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q3R3. I miss therapy twice a week
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q3R4. I miss therapy three times a week
|
4 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q3R5. I miss therapy four or more times a week
|
1 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q3R0. No response on frequency of missing therapy per week
|
6 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q4R1. The therapy is not effective as I never bring up sputum with therapy
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q4R2. The therapy is effective sometimes
|
11 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q4R3. The therapy is mostly effective
|
7 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q4R4. The therapy is almost always effective
|
4 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q4R5. I always bring up sputum with therapy
|
3 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q4R0. No answer on effectiveness of therapy in bringing up sputum
|
6 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q5R1. I always feel short of breath
|
0 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q5R2. I frequently have shortness of breath episodes
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q5R3. I have some shortness of breath episodes
|
3 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q5R4. I have a few shortness of breath episodes
|
12 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q5R5. I never have shortness of breath
|
8 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q5R0. No answer on effect of therapy on breathing
|
8 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q6R1. I do not feel the therapy helps my lungs stay healthy
|
1 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q6R2. I am unsure if this therapy helps my lungs stay healthy
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q6R3. This therapy seems somewhat helpful helpful for my lungs
|
3 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q6R4. I feel this therapy helps my lungs stay healthy
|
13 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q6R5. I definitely feel this therapy helps my lungs stay healthy
|
8 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy
|
6 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q7R1. My ability to perform daily tasks has definitely not improved
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q7R2. My ability to perform daily tasks has not improved
|
4 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q7R3. I am unsure if my ability to perform daily tasks has improved
|
7 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q7R4. I have had some improvement in ability to perform daily tasks
|
7 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q7R5. I have had significant improvement in ability to perform daily tasks
|
5 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q7R0. No answer on effect of current therapy on ability to perform daily tasks
|
8 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q8R1. I do not want to continue. I strongly prefer to use my previous therapy
|
3 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q8R3. I do not have a preference on which therapy I use
|
2 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q8R4. I prefer to continue to do therapy with the Volara System
|
9 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q8R5. I strongly prefer to continue to do therapy with the Volara System
|
8 Participants
|
|
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Q8R0. No answer given on therapy preference
|
9 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=33 participants at risk
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
|
|---|---|
|
Nervous system disorders
Seizure
|
3.0%
1/33 • Number of events 1 • Duration of participation for enrolled patients ranged from 16 days to 354 days.
All-Cause Mortality was assessed in all enrolled patients. Adverse events were assessed for the patients who received treatment using the Volara System.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
3.0%
1/33 • Number of events 1 • Duration of participation for enrolled patients ranged from 16 days to 354 days.
All-Cause Mortality was assessed in all enrolled patients. Adverse events were assessed for the patients who received treatment using the Volara System.
|
Additional Information
Baxter Clinical Trials Disclosure Call Center
Baxter Healthcare
Phone: (224) 948-7359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
- Publication restrictions are in place
Restriction type: OTHER