Trial Outcomes & Findings for Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy (NCT NCT03083379)
NCT ID: NCT03083379
Last Updated: 2018-06-14
Results Overview
EIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
2 months
Results posted on
2018-06-14
Participant Flow
Participant milestones
| Measure |
Volumetric Incentive Spirometry
Incentive Spirometry
Volumetric Incentive Spirometry: A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.
* Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.
* Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.
* The 10-breath cycle will be repeated three times with respiratory therapist coaching.
* Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.
* Incentive Spirometry therapy and monitoring session will last about 15 minutes
|
EzPAP® POSITIVE AIRWAY PRESSURE
EzPAP
EzPAP® POSITIVE AIRWAY PRESSURE: - A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.
* Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.
* Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.
* The 10-breath cycle will be repeated three times with respiratory therapist coaching.
* Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.
* EzPAP® therapy and monitoring sessions will last about 15 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy
Baseline characteristics by cohort
| Measure |
Volumetric Incentive Spirometry
n=15 Participants
Incentive Spirometry
Volumetric Incentive Spirometry: A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.
* Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.
* Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.
* The 10-breath cycle will be repeated three times with respiratory therapist coaching.
* Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.
* Incentive Spirometry therapy and monitoring session will last about 15 minutes
|
EzPAP® POSITIVE AIRWAY PRESSURE
n=15 Participants
EzPAP
EzPAP® POSITIVE AIRWAY PRESSURE: - A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.
* Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.
* Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.
* The 10-breath cycle will be repeated three times with respiratory therapist coaching.
* Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.
* EzPAP® therapy and monitoring sessions will last about 15 minutes
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
n=5 Participants
|
31 years
n=7 Participants
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Change in dorsal regional distribution of ventilation
|
2.9 Percent
n=5 Participants
|
2.8 Percent
n=7 Participants
|
2.8 Percent
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsEIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.
Outcome measures
| Measure |
Volumetric Incentive Spirometry
n=15 Participants
Incentive Spirometry
Volumetric Incentive Spirometry: A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.
* Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.
* Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.
* The 10-breath cycle will be repeated three times with respiratory therapist coaching.
* Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.
* Incentive Spirometry therapy and monitoring session will last about 15 minutes
|
EzPAP® POSITIVE AIRWAY PRESSURE
n=15 Participants
EzPAP
EzPAP® POSITIVE AIRWAY PRESSURE: - A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.
* Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.
* Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.
* The 10-breath cycle will be repeated three times with respiratory therapist coaching.
* Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.
* EzPAP® therapy and monitoring sessions will last about 15 minutes
|
|---|---|---|
|
Regional Distribution of Ventilation
|
-4.9 percentage of dorsal redistribution
Interval -15.9 to 6.0
|
-5.6 percentage of dorsal redistribution
Interval -14.0 to 2.7
|
Adverse Events
Volumetric Incentive Spirometry
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EzPAP® POSITIVE AIRWAY PRESSURE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Daniel D. Rowley, MSc, RRT-ACCS, FAARC
University of Virginia Health System
Phone: 434-465-7235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place