Trial Outcomes & Findings for The Use of High Frequency Oscillations With NIV in Hypercapnic COPD Participants (NCT NCT02680639)
NCT ID: NCT02680639
Last Updated: 2019-05-06
Results Overview
Transcutaneous carbon dioxide (TcCO2) monitoring is a non-invasive alternative to arterial blood sampling. Carbon Dioxide Levels will be measured for each participant as they complete each arm.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Baseline and 20 minutes
Results posted on
2019-05-06
Participant Flow
Participants were in enrolled from a single site in Pittsburgh PA. The study opened Mid 2015 with first enrollment November 2015 and continued into August 2016.
Participant milestones
| Measure |
Screening Period
All study participants that were consented to the study.
|
Optimal, Optimized P2P, Non-Optimized NP2P, Optimized NP2P
Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - non-optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - Optimized EPAP w/ no peak-to-peak last
|
Optimal, Optimized NP2P, Non-Optimized NP2P, Optimized NP2P
Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - Non-Optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - optimized EPAP w/ no peak-to-peak last
|
|---|---|---|---|
|
Screening Period
STARTED
|
10
|
0
|
0
|
|
Screening Period
COMPLETED
|
3
|
0
|
0
|
|
Screening Period
NOT COMPLETED
|
7
|
0
|
0
|
|
High Frequency Oscillation (HFO) Therapy
STARTED
|
0
|
2
|
1
|
|
High Frequency Oscillation (HFO) Therapy
COMPLETED
|
0
|
2
|
1
|
|
High Frequency Oscillation (HFO) Therapy
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Screening Period
All study participants that were consented to the study.
|
Optimal, Optimized P2P, Non-Optimized NP2P, Optimized NP2P
Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - non-optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - Optimized EPAP w/ no peak-to-peak last
|
Optimal, Optimized NP2P, Non-Optimized NP2P, Optimized NP2P
Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - Non-Optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - optimized EPAP w/ no peak-to-peak last
|
|---|---|---|---|
|
Screening Period
Screen Failure
|
7
|
0
|
0
|
Baseline Characteristics
The Use of High Frequency Oscillations With NIV in Hypercapnic COPD Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=10 Participants
All participants that signed consent.
|
|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 20 minutesTranscutaneous carbon dioxide (TcCO2) monitoring is a non-invasive alternative to arterial blood sampling. Carbon Dioxide Levels will be measured for each participant as they complete each arm.
Outcome measures
| Measure |
Optimal EPAP Determination
n=3 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes expiratory flow limitation (EFL). Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ no Peak-to-peak
n=3 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ Max Peak-to-peak
n=3 Participants
On the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Non-optimized EPAP w/ no Peak-to-peak
n=3 Participants
On the BiPAP Synchrony ventilator EPAP will be set at 4cmH2O and IPAP will be set at 10cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water).
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
|---|---|---|---|---|
|
Carbon Dioxide Levels
Baseline
|
57.8 mmHg
Standard Deviation 9.1
|
52.6 mmHg
Standard Deviation 7.1
|
53.1 mmHg
Standard Deviation 9.8
|
52.4 mmHg
Standard Deviation 8.5
|
|
Carbon Dioxide Levels
20 Minutes
|
51.1 mmHg
Standard Deviation 8.7
|
49.7 mmHg
Standard Deviation 6.0
|
50.2 mmHg
Standard Deviation 8.5
|
49.7 mmHg
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 20 minutesPopulation: Respiratory rate was not able to be obtained for one participant.
Minute ventilation in regards to respiratory rate and volume of gas exchanged will be measured for each participant as they complete each arm.
Outcome measures
| Measure |
Optimal EPAP Determination
n=2 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes expiratory flow limitation (EFL). Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ no Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ Max Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Non-optimized EPAP w/ no Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator EPAP will be set at 4cmH2O and IPAP will be set at 10cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water).
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
|---|---|---|---|---|
|
Respiratory Rate
|
18.5 breaths per minute
Standard Deviation 2.5
|
22 breaths per minute
Standard Deviation 3
|
23 breaths per minute
Standard Deviation 2
|
24 breaths per minute
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 20 minutesPopulation: Tidal volume was not able to be obtained for one participant.
Minute ventilation in regards to volume of gas exchanged will be measured for each participant as they complete each arm.
Outcome measures
| Measure |
Optimal EPAP Determination
n=2 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes expiratory flow limitation (EFL). Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ no Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ Max Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Non-optimized EPAP w/ no Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator EPAP will be set at 4cmH2O and IPAP will be set at 10cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water).
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
|---|---|---|---|---|
|
Tidal Volume
|
373 mL
Standard Deviation 77
|
272.5 mL
Standard Deviation 29.5
|
293 mL
Standard Deviation 26
|
253 mL
Standard Deviation 24
|
SECONDARY outcome
Timeframe: 20 minutesPopulation: Respiratory rate and Tidal volume were not able to be obtained for one participant. Therefore minute ventilation was not able to be calculated.
Minute Ventilation in regards to the diffusion state of the lungs and carbon dioxide will be measured for each participant as they complete each arm.
Outcome measures
| Measure |
Optimal EPAP Determination
n=2 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be automatically adjusted by the ventilator to find optimal EPAP that abolishes expiratory flow limitation (EFL). Peak-to-Peak pressure oscillations will be set at 2.5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ no Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator the EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Optimized EPAP w/ Max Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator EPAP (and IPAP) will be set at optimal pressure as determined by the Auto EPAP. Peak-to-Peak pressure oscillations will be set at 5 cmH2O (centimeters of water)
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
Non-optimized EPAP w/ no Peak-to-peak
n=2 Participants
On the BiPAP Synchrony ventilator EPAP will be set at 4cmH2O and IPAP will be set at 10cmH2O (centimeters of water). Peak-to-Peak pressure oscillations will be set at 0 cmH2O (centimeters of water).
BiPAP Synchrony ventilator: The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
|
|---|---|---|---|---|
|
Minute Ventilation for Carbon Dioxide
|
6708 mL/min
Standard Deviation 492
|
5906.5 mL/min
Standard Deviation 168.5
|
6791 mL/min
Standard Deviation 1184
|
6072 mL/min
Standard Deviation 576
|
Adverse Events
Screening Period
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Optimal, Optimized P2P, Non-Optimized NP2P, Optimized NP2P
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optimal, Optimized NP2P, Non-Optimized NP2P, Optimized P2P
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Screening Period
n=10 participants at risk
All study participants that were consented to the study.
|
Optimal, Optimized P2P, Non-Optimized NP2P, Optimized NP2P
n=2 participants at risk
Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - non-optimized EPAP w/ no peak-to-peak third, and Optimized NP2P - Optimized EPAP w/ no peak-to-peak last
|
Optimal, Optimized NP2P, Non-Optimized NP2P, Optimized P2P
n=1 participants at risk
Optimal - optimal EPAP determination first, Optimized P2P - Optimized EPAP w/ max peak-to-peak second, Non-Optimized NP2P - Non-Optimized EPAP w/ no peak-to-pea third, and Optimized P2P - optimized EPAP w/ peak-to-peak last
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
10.0%
1/10 • Number of events 1 • 10 days
|
0.00%
0/2 • 10 days
|
0.00%
0/1 • 10 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place