Trial Outcomes & Findings for Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS) (NCT NCT04581811)

NCT ID: NCT04581811

Last Updated: 2022-03-31

Results Overview

Time spent in the prone position of hours eligible for prone positioning

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 96 hours
• Results posted on: 2022-03-31

Participant Flow

Participant milestones

Measure	Prolonged Proning Arm Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study Prolonged Proned Positioning: Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period	Traditional Proning Arm Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study Traditional Proning Arm: Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period
Overall Study STARTED	26	26
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)

Baseline characteristics by cohort

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study Prolonged Proned Positioning: Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study Traditional Proning Arm: Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 14 • n=5 Participants	62 years STANDARD_DEVIATION 12 • n=7 Participants	63 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	13 Participants n=7 Participants	25 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	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 96 hours

Time spent in the prone position of hours eligible for prone positioning

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Duration in Prone Position	56.6 hours Standard Deviation 20.6	45.7 hours Standard Deviation 20.8

SECONDARY outcome

Timeframe: End of supine session on day 4

Change in PaO2 on ABG to FiO2 ratio from immediately prior to initiation of prone positioning to end of study period

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Change in P:F Ratio	46.6 Ratio Standard Deviation 39.9	44.3 Ratio Standard Deviation 63.7

SECONDARY outcome

Timeframe: End of supine session on day 4

Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Change in Drive Pressure	0.16 cm H20 Standard Deviation 3.26	0.88 cm H20 Standard Deviation 4.95

SECONDARY outcome

Timeframe: End of supine session on day 4

Number of unplanned extubations

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Unplanned Extubations	0 Unplanned Extubations	1 Unplanned Extubations

SECONDARY outcome

Timeframe: End of supine session on day 4

Number of patients with pressure ulcers

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Pressure Ulcers	1 Participants	0 Participants

SECONDARY outcome

Timeframe: End of supine session on day 4

Number of displaced central venous line or arterial line

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Line Displacement	0 Central Venous or Arterial LineDislodged	1 Central Venous or Arterial LineDislodged

SECONDARY outcome

Timeframe: 30 days

Number of days free from mechanical ventilation

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Vent Free Days	6.27 days Standard Deviation 9.15	5.81 days Standard Deviation 9.28

SECONDARY outcome

Timeframe: 30 days

Mortality at 30 days

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Mortality	14 Participants	15 Participants

SECONDARY outcome

Timeframe: 96 hours

Patients in which new initiation of inhaled pulmonary vasodilators, ECMO

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Rescue Interventions	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days

Number of patients who have placement of tracheostomy

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Tracheostomy	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

Number of days not in ICU

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
ICU Free Days	4.35 days Standard Deviation 7.14	4.15 days Standard Deviation 7.52

SECONDARY outcome

Timeframe: 96 hours

Ratio of SpO2 to FiO2

Outcome measures

Measure	Prolonged Proning Arm n=26 Participants Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study	Traditional Proning Arm n=26 Participants Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
S:F Ratio	1.70 Ratio Standard Deviation 0.48	1.69 Ratio Standard Deviation 0.52

Adverse Events

Prolonged Proning Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

Traditional Proning Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Page - PI

UAB Hospital

Phone: 205-975-7387

Email: dpage1@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place