Trial Outcomes & Findings for Pressure Variability Study (NCT NCT02943941)
NCT ID: NCT02943941
Last Updated: 2019-04-12
Results Overview
Posture defined as lying left side down compared to baseline supine
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Results posted on
2019-04-12
Participant Flow
Participant milestones
| Measure |
Single Arm Design
Single arm (all participants)
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pressure Variability Study
Baseline characteristics by cohort
| Measure |
Single Arm
n=16 Participants
Single arm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)Population: Only 14 patients able to provide data to contribute to analysis.
Posture defined as lying left side down compared to baseline supine
Outcome measures
| Measure |
Single Arm Design
n=14 Participants
Single arm
|
|---|---|
|
Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
|
27.7 mmHg
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.
Outcome measures
| Measure |
Single Arm Design
n=16 Participants
Single arm
|
|---|---|
|
Change in PAP During Change in Respiration
|
25.9 mmHg
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)Outcome measures
| Measure |
Single Arm Design
n=14 Participants
Single arm
|
|---|---|
|
Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
|
27.7 mmHg
Standard Deviation 12.2
|
Adverse Events
Single Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place