Trial Outcomes & Findings for COVID-19 Patient Positioning Pragmatic Trial (NCT NCT04359797)
NCT ID: NCT04359797
Last Updated: 2021-12-27
Results Overview
The highest level of support on the 5th day after enrollment according to the following scale adjusted for patient status at enrollment according to the same scale and ranked by mean FIO2 within each category, as appropriate. * Death * ECMO * Mechanical ventilation (ranked by mean FIO2) * Non-invasive ventilation such as BiPAP (ranked by mean FIO2) * High flow nasal cannula, e.g. Optiflow, Vapotherm or other similar device (titrated by FiO2%) (ranked by mean FIO2) * Standard nasal cannula (titrated by L/min up to 15 L/min) or face mask (ranked by mean FIO2) * Room air
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
501 participants
Primary outcome timeframe
5 days post-randomization
Results posted on
2021-12-27
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.
Usual Care: No provider-recommendation, patients will remain in their natural choice of position
|
Prone
Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.
Prone: Provider-recommended guidance on prone positioning of patients
|
|---|---|---|
|
Overall Study
STARTED
|
243
|
258
|
|
Overall Study
COMPLETED
|
243
|
258
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Patient Positioning Pragmatic Trial
Baseline characteristics by cohort
| Measure |
Usual Care
n=243 Participants
Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.
Usual Care: No provider-recommendation, patients will remain in their natural choice of position
|
Prone
n=258 Participants
Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.
Prone: Provider-recommended guidance on prone positioning of patients
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
162 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
43 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other race
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown race
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic/Latinx
|
204 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/Latinx
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown ethnicity
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
243 participants
n=5 Participants
|
258 participants
n=7 Participants
|
501 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 days post-randomizationThe highest level of support on the 5th day after enrollment according to the following scale adjusted for patient status at enrollment according to the same scale and ranked by mean FIO2 within each category, as appropriate. * Death * ECMO * Mechanical ventilation (ranked by mean FIO2) * Non-invasive ventilation such as BiPAP (ranked by mean FIO2) * High flow nasal cannula, e.g. Optiflow, Vapotherm or other similar device (titrated by FiO2%) (ranked by mean FIO2) * Standard nasal cannula (titrated by L/min up to 15 L/min) or face mask (ranked by mean FIO2) * Room air
Outcome measures
| Measure |
Usual Care
n=243 Participants
Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.
Usual Care: No provider-recommendation, patients will remain in their natural choice of position
|
Prone
n=258 Participants
Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.
Prone: Provider-recommended guidance on prone positioning of patients
|
|---|---|---|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
Discharged
|
109 Participants
|
99 Participants
|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
Room Air
|
15 Participants
|
15 Participants
|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
Standard Nasal Cannula
|
57 Participants
|
65 Participants
|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
High Flow Nasal Cannula
|
16 Participants
|
16 Participants
|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
Non-invasive Ventilation
|
26 Participants
|
24 Participants
|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
Mechanical Ventilation
|
10 Participants
|
19 Participants
|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
ECMO
|
1 Participants
|
1 Participants
|
|
Number of Participants Categorized on the Modified WHO Ordinal Scale by the Highest Level of Support on Day 5
Death
|
9 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: First 5 days post-randomizationFor each day, the investigators will record the most intensive oxygen delivery mode and then, for that highest level of oxygen support device, the max FiO2 while exposed to that device.
Outcome measures
| Measure |
Usual Care
n=243 Participants
Participants randomized to this arm will remain in their natural choice of position, which is anticipated to favor a supine, semi-recumbent position.
Usual Care: No provider-recommendation, patients will remain in their natural choice of position
|
Prone
n=258 Participants
Participants randomized to this arm will be encouraged to lay in a completely prone position for as much time as is tolerable during hospitalization.
Prone: Provider-recommended guidance on prone positioning of patients
|
|---|---|---|
|
FIO2
Day 3
|
39.3 percentage of inspired oxygen
Standard Deviation 29.8
|
43.6 percentage of inspired oxygen
Standard Deviation 32.1
|
|
FIO2
Day 1
|
40.4 percentage of inspired oxygen
Standard Deviation 27.1
|
45.3 percentage of inspired oxygen
Standard Deviation 29.1
|
|
FIO2
Day 2
|
40.3 percentage of inspired oxygen
Standard Deviation 28.2
|
44.0 percentage of inspired oxygen
Standard Deviation 30.9
|
|
FIO2
Day 4
|
37.8 percentage of inspired oxygen
Standard Deviation 30.2
|
42.7 percentage of inspired oxygen
Standard Deviation 32.5
|
|
FIO2
Day 5
|
37.1 percentage of inspired oxygen
Standard Deviation 31.0
|
40.6 percentage of inspired oxygen
Standard Deviation 32.0
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 48 deaths
Prone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 63 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Edward T. Qian
Vanderbilt University Medical Center
Phone: 615-322-2386
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place