Trial Outcomes & Findings for High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) (NCT NCT01214200)
NCT ID: NCT01214200
Last Updated: 2019-01-02
Results Overview
Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Before and after 3 months of therapy
Results posted on
2019-01-02
Participant Flow
Participant milestones
| Measure |
High Intensity Non Invasive Pos.Pressure
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic Chronic Obstructive Pulmonary Diseased (COPD) participants that meet eligibility criteria will receive HINPPV for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O (centimeters of water); or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
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|---|---|
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Overall Study
STARTED
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20
|
|
Overall Study
COMPLETED
|
9
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Overall Study
NOT COMPLETED
|
11
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Reasons for withdrawal
| Measure |
High Intensity Non Invasive Pos.Pressure
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic Chronic Obstructive Pulmonary Diseased (COPD) participants that meet eligibility criteria will receive HINPPV for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O (centimeters of water); or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
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|---|---|
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Overall Study
Did not meet inclusion/exclusion
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9
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)
Baseline characteristics by cohort
| Measure |
High Intensity Non Invasive Pos.Pressure
n=9 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
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|---|---|
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Age, Continuous
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64.4 years
STANDARD_DEVIATION 6.6 • n=99 Participants
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|
Sex: Female, Male
Female
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7 Participants
n=99 Participants
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Sex: Female, Male
Male
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2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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9 Participants
n=99 Participants
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Forced Expiratory Volume 1 sec (FEV1s)
|
26 percent of predicted
STANDARD_DEVIATION 6.73 • n=99 Participants
|
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BMI
|
26.6 kg/m^2
n=99 Participants
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Cigarette Usage
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55 packs per year
n=99 Participants
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PRIMARY outcome
Timeframe: Before and after 3 months of therapyDaytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=9 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
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After Exertion
All participants completed the modified Borg scale after exertion (6 minute walk test).
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|---|---|---|
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Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Baseline
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53 mmHg
Interval 52.9 to 60.5
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—
|
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Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
3 months
|
50 mmHg
Interval 47.5 to 54.5
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—
|
SECONDARY outcome
Timeframe: Before and after 3 months of therapyHealth status was assessed by completing different surveys at baseline and after 3 months of therapy. The Calgary Sleep Apnea Quality of Life was administered at baseline and 3 months. It is a 35-item, interview-administered scale, the SAQLI evaluates four domains of quality of life associated with sleep apnea: daily functioning, social interactions, emotional functioning, and symptoms. The SAQLI use a 7-point Likert scale ranging from 1 (maximal impairment) to 7 (no impairment).
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=9 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
|
After Exertion
All participants completed the modified Borg scale after exertion (6 minute walk test).
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|---|---|---|
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Health Status
Baseline
|
4.34 units on a scale
Interval 3.44 to 5.6
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—
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Health Status
3 months
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4.78 units on a scale
Interval 4.64 to 5.6
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—
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SECONDARY outcome
Timeframe: Before and after 3 months of therapyThe Maximal inspiratory pressure (MIP) is the maximum negative pressure that can be generated from one inspiratory effort starting from functional residual capacity (FRC) or residual volume (RV). This was assessed at baseline and after 3 months of therapy.
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=9 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
|
After Exertion
All participants completed the modified Borg scale after exertion (6 minute walk test).
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|---|---|---|
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Maximal Inspiratory Pressure
Baseline
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7.04 kPa
Interval 3.67 to 7.97
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—
|
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Maximal Inspiratory Pressure
3 months
|
6.85 kPa
Interval 3.9 to 8.3
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—
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SECONDARY outcome
Timeframe: Before and after 3 months of therapyExercise capacity will be measured by comparing the 6 minute walk test as measured in meters from baseline to 3 months
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=9 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
|
After Exertion
All participants completed the modified Borg scale after exertion (6 minute walk test).
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|---|---|---|
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Exercise Capacity
Baseline
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211 meters
Standard Deviation 54
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—
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Exercise Capacity
3 months
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236 meters
Standard Deviation 80
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—
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SECONDARY outcome
Timeframe: Before and after 3 months of therapyThe modifed Borg scale was used to measure dyspnea. The Dyspnea Borg scale measures patients perceived level of dyspnea. The scale ranges from 0 to 10, 0- nothing at all and 10 is maximal.
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=9 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
|
After Exertion
n=9 Participants
All participants completed the modified Borg scale after exertion (6 minute walk test).
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|---|---|---|
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Dyspnea at Rest and With Exertion
Baseline
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0.7 units on a scale
Standard Deviation 1.3
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6.9 units on a scale
Standard Deviation 1.7
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Dyspnea at Rest and With Exertion
3 months
|
0.6 units on a scale
Standard Deviation 1.1
|
4.6 units on a scale
Standard Deviation 1.7
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SECONDARY outcome
Timeframe: Before and after 3 months of therapyPopulation: Only 5 participants completed the overnight polysomnography (PSG) for this trial.
Sleepiness will be evaluated by measuring the the baseline and 3 month Epworth Sleepiness Scale. The Epworth Sleepiness Scale is an 8 question survey regarding daytime sleepiness. The higher the score the higher the chance of dozing during the day. Each question is rated on a 0 to 3 scale of chance of dozing or sleeping. 0 would be no chance, 3 would be the highest chance.
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=5 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
|
After Exertion
All participants completed the modified Borg scale after exertion (6 minute walk test).
|
|---|---|---|
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Sleepiness
Baseline
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9.3 units on a scale
Standard Deviation 2.6
|
—
|
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Sleepiness
3 months
|
7.2 units on a scale
Standard Deviation 3.3
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—
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SECONDARY outcome
Timeframe: Before and after 3 months of therapyPopulation: Only 5 participants completed the overnight PSG for this trial.
Duration of sleep will be measured using total sleep time. Total sleep time is the overall number of minutes of sleep, this will be compared from baseline to 3 months.
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=5 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
|
After Exertion
All participants completed the modified Borg scale after exertion (6 minute walk test).
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|---|---|---|
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Duration of Sleep
3 months
|
337 minutes per night
Standard Deviation 34
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—
|
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Duration of Sleep
Baseline
|
329 minutes per night
Standard Deviation 62.5
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—
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SECONDARY outcome
Timeframe: Before and after 3 months of therapyPopulation: Only 5 participants completed the overnight PSG for this trial.
Sleep efficiency will be measured by taking the total sleep time by the total time in bed. This is measured as a percentage and compared from baseline to 3 months
Outcome measures
| Measure |
High Intensity Non Invasive Pos.Pressure
n=5 Participants
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
|
After Exertion
All participants completed the modified Borg scale after exertion (6 minute walk test).
|
|---|---|---|
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Efficiency of Sleep
Baseline
|
80.6 percentage of efficiency
Standard Deviation 12.7
|
—
|
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Efficiency of Sleep
3 months
|
83.6 percentage of efficiency
Standard Deviation 6.7
|
—
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Adverse Events
High Intensity Non Invasive Pos.Pressure
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Intensity Non Invasive Pos.Pressure
n=9 participants at risk
The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
44.4%
4/9 • Number of events 4
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place