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Trial record 64 of 667 for:    CARBON DIOXIDE AND arterial

High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) (HINPPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01214200
Recruitment Status : Completed
First Posted : October 4, 2010
Results First Posted : January 1, 2019
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Intervention Device: Bilevel positive airway pressure (BiPAP)
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Completed 9
Not Completed 11
Reason Not Completed
Did not meet inclusion/exclusion             9
Withdrawal by Subject             2
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
Demographics were only evaluated on those that consented and completed the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
64.4  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
7
  77.8%
Male
2
  22.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
 100.0%
Forced Expiratory Volume 1 sec (FEV1s)  
Mean (Standard Deviation)
Unit of measure:  Percent of predicted
Number Analyzed 9 participants
26  (6.73)
BMI  
Mean (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 9 participants
26.6
(25.5 to 32.5)
Cigarette Usage  
Median (Inter-Quartile Range)
Unit of measure:  Packs per year
Number Analyzed 9 participants
55
(45 to 90)
1.Primary Outcome
Title Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Hide Description Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Mean (Inter-Quartile Range)
Unit of Measure: mmHg
Baseline
53
(52.9 to 60.5)
3 months
50
(47.5 to 54.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Intensity Non Invasive Pos.Pressure
Comments [Not Specified]
Type of Statistical Test Other
Comments For the analysis of differences between pre and post treatment a student’s t-test was used and was checked with the Wilcoxon signed rank test. A p<0.05 was considered statistically significant.
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon Signed Ranks Test
Comments [Not Specified]
2.Secondary Outcome
Title Health Status
Hide Description Health 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).
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
Baseline
4.34
(3.44 to 5.6)
3 months
4.78
(4.64 to 5.6)
3.Secondary Outcome
Title Maximal Inspiratory Pressure
Hide Description The 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.
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Mean (Inter-Quartile Range)
Unit of Measure: kPa
Baseline
7.04
(3.67 to 7.97)
3 months
6.85
(3.9 to 8.3)
4.Secondary Outcome
Title Exercise Capacity
Hide Description Exercise capacity will be measured by comparing the 6 minute walk test as measured in meters from baseline to 3 months
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: meters
Baseline 211  (54)
3 months 236  (80)
5.Secondary Outcome
Title Dyspnea at Rest and With Exertion
Hide Description The 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.
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title At Rest After Exertion
Hide Arm/Group Description:
All participants competed the modifed Borg scale at rest, prior to exercise.
All participants completed the modified Borg scale after exertion (6 minute walk test).
Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.7  (1.3) 6.9  (1.7)
3 months 0.6  (1.1) 4.6  (1.7)
6.Secondary Outcome
Title Sleepiness
Hide Description 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.
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 participants completed the overnight polysomnography (PSG) for this trial.
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 9.3  (2.6)
3 months 7.2  (3.3)
7.Secondary Outcome
Title Duration of Sleep
Hide Description 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.
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 participants completed the overnight PSG for this trial.
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: minutes per night
Baseline 329  (62.5)
3 months 337  (34)
8.Secondary Outcome
Title Efficiency of Sleep
Hide Description 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
Time Frame Before and after 3 months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 participants completed the overnight PSG for this trial.
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percentage of efficiency
Baseline 80.6  (12.7)
3 months 83.6  (6.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Intensity Non Invasive Pos.Pressure
Hide Arm/Group Description 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.
All-Cause Mortality
High Intensity Non Invasive Pos.Pressure
Affected / at Risk (%)
Total   0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
High Intensity Non Invasive Pos.Pressure
Affected / at Risk (%) # Events
Total   4/9 (44.44%)    
Respiratory, thoracic and mediastinal disorders   
COPD exacerbation *  4/9 (44.44%)  4
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Intensity Non Invasive Pos.Pressure
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Weir, MBChB
Organization: Temple University School of Medicine
Phone: 215-707-5864
EMail: mark.weir@tuhs.temple.edu
Layout table for additonal information
Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01214200     History of Changes
Other Study ID Numbers: HRC-0927-HINPPV-MS
First Submitted: June 29, 2010
First Posted: October 4, 2010
Results First Submitted: October 19, 2018
Results First Posted: January 1, 2019
Last Update Posted: January 1, 2019