Trial Outcomes & Findings for HVNI Ambulation Feasibility Study (NCT NCT03885726)
NCT ID: NCT03885726
Last Updated: 2020-10-19
Results Overview
Defined as the distance of patient ambulation
COMPLETED
NA
32 participants
Through study completion, an average of 1 day
2020-10-19
Participant Flow
Recruitment for this study took place in both an inpatient hospital setting and an outpatient medical clinic setting.
Of the N=32 enrolled patients, only N=28 completed both study arms. An additional N=3 patients were excluded from study analysis, making the total number of patient data analyzed post-hoc N=25.
Participant milestones
| Measure |
All Study Participants
Crossover study design with the first intervention as "Treatment as Usual - 6 minute walk test" (TAU), followed by an adequate recovery period. The second intervention was "High Velocity Nasal Insufflation - 6 minute walk test" (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Study Participants
Crossover study design with the first intervention as "Treatment as Usual - 6 minute walk test" (TAU), followed by an adequate recovery period. The second intervention was "High Velocity Nasal Insufflation - 6 minute walk test" (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients.
|
|---|---|
|
Overall Study
Staffing issues/lost interest
|
1
|
|
Overall Study
Early discharge from hospital
|
3
|
Baseline Characteristics
Out of the N=28 patients who completed both arms of the study, N=3 were excluded post-hoc, making the total analysis population N=25.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=25 Participants
Crossover study design with the first intervention as "Treatment as Usual - 6 minute walk test" (TAU), followed by an adequate recovery period. The second intervention was "High Velocity Nasal Insufflation - 6 minute walk test" (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients.
|
|---|---|
|
Age, Continuous
|
66 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=25 Participants • Out of the N=28 patients who completed both arms of the study, N=3 were excluded post-hoc, making the total analysis population N=25.
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants • Out of the N=28 patients who completed both arms of the study, N=3 were excluded post-hoc, making the total analysis population N=25.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants • N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
Defined as the distance of patient ambulation
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Exercise Performance- Distance
|
78.8 meters
Interval 63.0 to 144.1
|
88.6 meters
Interval 75.3 to 172.6
|
182.9 meters
Interval 134.1 to 453.4
|
165.2 meters
Interval 136.9 to 455.2
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
Defined as the duration of patient ambulation
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Exercise Performance- Duration
|
211.5 seconds
Interval 139.5 to 376.5
|
229.5 seconds
Interval 164.3 to 387.0
|
307 seconds
Interval 192.5 to 452.5
|
250 seconds
Interval 180.0 to 537.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
Defined as recovery time (return time to baseline rated perceived dyspnea).
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Patient Recovery Interval
|
283.5 seconds
Interval 232.0 to 462.3
|
191.5 seconds
Interval 172.0 to 395.5
|
239 seconds
Interval 143.0 to 330.0
|
245 seconds
Interval 135.5 to 359.5
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Patient blood pressure (systolic) measured in mmHg
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Patient Vital Signs - Blood Pressure
|
125.5 mmHg
Interval 119.8 to 152.5
|
137 mmHg
Interval 114.8 to 141.5
|
129 mmHg
Interval 120.0 to 132.0
|
113 mmHg
Interval 110.0 to 120.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Heart rate in bpm
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
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Patient Vital Signs-- Heart Rate [HR]
|
101 beats per minute (bpm)
Interval 88.3 to 108.3
|
94 beats per minute (bpm)
Interval 89.8 to 103.5
|
81 beats per minute (bpm)
Interval 72.0 to 89.0
|
79 beats per minute (bpm)
Interval 75.0 to 82.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Respiratory rate in breaths per minute
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Patient Vital Signs-- Respiratory Rate [RR]
|
20 breaths per minute (brpm)
Interval 17.5 to 20.0
|
18 breaths per minute (brpm)
Interval 17.5 to 20.0
|
20 breaths per minute (brpm)
Interval 18.0 to 20.0
|
20 breaths per minute (brpm)
Interval 18.0 to 20.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
SpO2 measured as percentage of oxygen saturation (%).
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Patient Vital Signs-- Arterial Oxygen Saturation
|
95 percentage of oxygen saturation (%)
Interval 93.0 to 97.3
|
95 percentage of oxygen saturation (%)
Interval 93.0 to 98.0
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95 percentage of oxygen saturation (%)
Interval 94.0 to 95.0
|
95 percentage of oxygen saturation (%)
Interval 93.0 to 97.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Patient's subjective assessment of their exertion, rated as a modified Borg score on a scale from 0 to 10 . Higher scores indicate a worse outcome.
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
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Patient Vital Signs-- Rated Perceived Exertion (RPE)
|
1.5 score on a scale
Interval 0.0 to 3.0
|
0.5 score on a scale
Interval 0.0 to 1.25
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0 score on a scale
Interval 0.0 to 0.5
|
0.5 score on a scale
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
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Patient Vital Signs-- Rated Perceived Dyspnea (RPD)
|
0.5 score on a scale
Interval 0.0 to 2.0
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0.75 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.5
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0 score on a scale
Interval 0.0 to 0.0
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SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Clinician's subjective assessment of the patient's clinical response to the therapy, rated as units on a visual analog scale from 0 to 100. A lower score indicates a better outcome.
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
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Clinician Perception Score- Patient Response to Therapy
|
44.5 units on a scale
Interval 3.38 to 69.5
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8.25 units on a scale
Interval 1.13 to 61.5
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9 units on a scale
Interval 3.0 to 49.5
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37.5 units on a scale
Interval 15.0 to 58.5
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Clinician's subjective assessment of the patient's comfort on and tolerance of the therapy, rated as units on a visual analog scale from 0 to 100. Lower values indicate a better outcome.
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
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Clinician Perception Score- Patient Tolerance and Comfort
|
33.8 units on a scale
Interval 1.75 to 69.3
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4 units on a scale
Interval 1.25 to 17.1
|
1 units on a scale
Interval 0.0 to 20.5
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19 units on a scale
Interval 8.5 to 82.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Clinician's subjective assessment of the frequency of technical or clinical issues during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Clinician Perception Score- Frequency of Technical/Clinical Difficulties
|
1.5 units on a scale
Interval 1.0 to 4.5
|
1.5 units on a scale
Interval 0.5 to 6.38
|
1 units on a scale
Interval 0.0 to 2.5
|
3 units on a scale
Interval 0.5 to 17.5
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of the N=32 patients enrolled in the study, N=28 completed all study arms. An additional N=3 were excluded from post-hoc analysis, making the final analysis N=25.
Clinician's subjective assessment of the the simplicity of setting up and using the equipment, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
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Clinician Perception Score- Simplicity of Set-up and Use
|
1 units on a scale
Interval 0.25 to 2.25
|
1.5 units on a scale
Interval 0.0 to 2.5
|
1 units on a scale
Interval 0.5 to 2.75
|
2 units on a scale
Interval 0.75 to 3.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Clinician's subjective assessment of the amount of support and adjustment required from the clinician during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=13 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Clinician Perception Score- Support/Adjustment Required
|
2 units on a scale
Interval 0.25 to 11.3
|
2 units on a scale
Interval 0.5 to 20.3
|
18.5 units on a scale
Interval 1.0 to 33.8
|
18.5 units on a scale
Interval 0.5 to 48.3
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPopulation: Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Patient blood pressure (diastolic) measured in mmHg
Outcome measures
| Measure |
Treatment as Usual (Inpatient)
n=16 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Inpatient)
n=16 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
Treatment as Usual (Outpatient)
n=9 Participants
Treatment as Usual: Conventional therapy per institution
|
High Velocity Nasal Insufflation (Outpatient)
n=9 Participants
Precision Flow Plus: High Velocity Nasal Insufflation
|
|---|---|---|---|---|
|
Patient Vital Signs - Blood Pressure
|
2 mmHg
Interval 0.25 to 11.3
|
2 mmHg
Interval 0.5 to 20.3
|
18.5 mmHg
Interval 1.0 to 33.8
|
18.5 mmHg
Interval 0.5 to 48.3
|
Adverse Events
Treatment as Usual
High Velocity Nasal Insufflation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place