Trial Outcomes & Findings for Comparison Between a Novel Proning Pillow System and Standard Pillows (NCT NCT05149989)
NCT ID: NCT05149989
Last Updated: 2024-08-22
Results Overview
The maximum values of pressure measured by the two pressure mats, one placed in the chest region and on in the pelvis region, measured in mmHg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
10 minutes
Results posted on
2024-08-22
Participant Flow
Participant milestones
| Measure |
Proning
Proned on standard and proning pillows
Proning Pillow System: Participants will be asked to lie on the proning pillows in prone position for no more than 5 minutes. Each participant will then be asked to lie on standard hospital pillows for no more than 5 minutes.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Proning
n=50 Participants
Proned on standard and proning pillows
Proning Pillow System: Participants will be asked to lie on the proning pillows in prone position for no more than 5 minutes. Each participant will then be asked to lie on standard hospital pillows for no more than 5 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=50 Participants
|
|
Region of Enrollment
United Kingdom
|
50 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: Population was analysed in two separate groups: male (20) and female (30)
The maximum values of pressure measured by the two pressure mats, one placed in the chest region and on in the pelvis region, measured in mmHg.
Outcome measures
| Measure |
Proning
n=50 Participants
Proned on standard and proning pillows
Proning Pillow System: Participants will be asked to lie on the proning pillows in prone position for no more than 5 minutes. Each participant will then be asked to lie on standard hospital pillows for no more than 5 minutes.
|
|---|---|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: proning pillow, chest, male
|
88.1 mmHg
Interval 77.3 to 99.3
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: standard pillow, chest, male
|
71.5 mmHg
Interval 59.0 to 72.2
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: proning pillow, chest, female
|
69.6 mmHg
Interval 61.9 to 78.8
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: standard pillow, chest, female
|
64.3 mmHg
Interval 59.7 to 74.4
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: proning pillow, pelvis, healthy males
|
70.4 mmHg
Interval 53.6 to 84.7
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: standard pillow, pelvis, healthy males
|
40.2 mmHg
Interval 35.3 to 44.9
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: proning pillow, pelvis, overweight males
|
96.3 mmHg
Interval 82.0 to 107.2
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: standard pillow, pelvis, overweight males
|
47.1 mmHg
Interval 39.8 to 54.0
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: proning pillow, pelvis, healthy females
|
86.0 mmHg
Interval 68.2 to 94.4
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: standard pillow, pelvis, healthy females
|
45.5 mmHg
Interval 36.6 to 53.1
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: proning pillow, pelvis, overweight females
|
84.4 mmHg
Interval 68.7 to 94.4
|
|
Peak Chest and Pelvis Interface Pressures
Peak pressure: standard pillow, pelvis, overweight females
|
45.0 mmHg
Interval 40.8 to 50.8
|
Adverse Events
Proning
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
Dr Tristan Payne
Liverpool University Hospitals NHS Foundation Trust
Phone: +44(0)1517064553
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place