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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT04581811
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.

Condition or Disease	Intervention/Treatment	Phase
ARDS; Covid19; Acute Hypoxemic Respiratory Failure	Other: Prolonged Proned Positioning; Other: Traditional Proning Arm	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study
• Actual Study Start Date: Nov 10, 2020
• Actual Primary Completion Date: Mar 20, 2021
• Actual Study Completion Date: Mar 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: 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
Active Comparator: 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	Other: 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

Outcome Measures

Primary Outcome Measures

1. Duration in Prone Position [96 hours]

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

Secondary Outcome Measures

1. Change in P:F Ratio [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

2. Change in Drive Pressure [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

3. Unplanned Extubations [End of supine session on day 4]

   Number of unplanned extubations

4. Pressure Ulcers [End of supine session on day 4]

   Number of patients with pressure ulcers

5. Line Displacement [End of supine session on day 4]

   Number of displaced central venous line or arterial line

6. Vent Free Days [30 days]

   Number of days free from mechanical ventilation

7. Mortality [30 days]

   Mortality at 30 days

8. Rescue Interventions [96 hours]

   Patients in which new initiation of inhaled pulmonary vasodilators, ECMO

9. Tracheostomy [30 days]

   Number of patients who have placement of tracheostomy

10. ICU Free Days [30 days]

    Number of days not in ICU

11. S:F Ratio [96 hours]

    Ratio of SpO2 to FiO2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Positive COVID test Endotracheal Intubation P:F <150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU.

Exclusion Criteria:

Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for >48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2020

More Information

Publications

None provided.

• Responsible Party: David Page, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04581811
• Other Study ID Numbers: IRB-300005979
• First Posted: Oct 9, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury

Study Results

Participant Flow

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	26	26
COMPLETED	26	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	26	26	52
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 50%	14 53.8%	27 51.9%
>=65 years	13 50%	12 46.2%	25 48.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (14)	62 (12)	63 (13)
Sex: Female, Male (Count of Participants)
Female	11 42.3%	9 34.6%	20 38.5%
Male	15 57.7%	17 65.4%	32 61.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 42.3%	12 46.2%	23 44.2%
White	12 46.2%	13 50%	25 48.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 11.5%	1 3.8%	4 7.7%

Outcome Measures

1. Primary Outcome

Title	Duration in Prone Position
Description	Time spent in the prone position of hours eligible for prone positioning
Time Frame	96 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Mean (Standard Deviation) [hours]	56.6 (20.6)	45.7 (20.8)

2. Secondary Outcome

Title	Change in P:F Ratio
Description	Change in PaO2 on ABG to FiO2 ratio from immediately prior to initiation of prone positioning to end of study period
Time Frame	End of supine session on day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Mean (Standard Deviation) [Ratio]	46.6 (39.9)	44.3 (63.7)

3. Secondary Outcome

Title	Change in Drive Pressure
Description	Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period
Time Frame	End of supine session on day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Mean (Standard Deviation) [cm H20]	0.16 (3.26)	0.88 (4.95)

4. Secondary Outcome

Title	Unplanned Extubations
Description	Number of unplanned extubations
Time Frame	End of supine session on day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Number [Unplanned Extubations]	0	1

5. Secondary Outcome

Title	Pressure Ulcers
Description	Number of patients with pressure ulcers
Time Frame	End of supine session on day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Count of Participants [Participants]	1 3.8%	0 0%

6. Secondary Outcome

Title	Line Displacement
Description	Number of displaced central venous line or arterial line
Time Frame	End of supine session on day 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Number [Central Venous or Arterial LineDislodged]	0	1

7. Secondary Outcome

Title	Vent Free Days
Description	Number of days free from mechanical ventilation
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Mean (Standard Deviation) [days]	6.27 (9.15)	5.81 (9.28)

8. Secondary Outcome

Title	Mortality
Description	Mortality at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Count of Participants [Participants]	14 53.8%	15 57.7%

9. Secondary Outcome

Title	Rescue Interventions
Description	Patients in which new initiation of inhaled pulmonary vasodilators, ECMO
Time Frame	96 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Count of Participants [Participants]	0 0%	1 3.8%

10. Secondary Outcome

Title	Tracheostomy
Description	Number of patients who have placement of tracheostomy
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Count of Participants [Participants]	6 23.1%	3 11.5%

11. Secondary Outcome

Title	ICU Free Days
Description	Number of days not in ICU
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Mean (Standard Deviation) [days]	4.35 (7.14)	4.15 (7.52)

12. Secondary Outcome

Title	S:F Ratio
Description	Ratio of SpO2 to FiO2
Time Frame	96 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Proning Arm	Traditional Proning Arm
Arm/Group Description	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	Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
Measure Participants	26	26
Mean (Standard Deviation) [Ratio]	1.70 (0.48)	1.69 (0.52)

Adverse Events

Time Frame	30 days
Arm/Group Title	Prolonged Proning Arm		Traditional Proning Arm
Arm/Group Description	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		Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study
All Cause Mortality
	Prolonged Proning Arm		Traditional Proning Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/26 (53.8%)		15/26 (57.7%)
Serious Adverse Events
	Prolonged Proning Arm		Traditional Proning Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Prolonged Proning Arm		Traditional Proning Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.