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

Not Applicable

Completed

• Conditions: ARDS; Covid19; Acute Hypoxemic Respiratory Failure
• Interventions: Other: Prolonged Proned Positioning; Other: Traditional Proning Arm

• Registration Number: NCT04581811
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-09
• Study Start: 2020-11-10
• Primary Completion: 2021-03-20
• Study Completion: 2021-03-20
• Results First Submitted: 2022-02-25
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Results First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Proning Arm	Prolonged Proned Positioning	Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study
Traditional Proning Arm	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

Primary Outcome Measures

Name	Time	Method
Duration in Prone Position	96 hours	Time spent in the prone position of hours eligible for prone positioning

Secondary Outcome Measures

Name	Time	Method
Unplanned Extubations	End of supine session on day 4	Number of unplanned extubations
Line Displacement	End of supine session on day 4	Number of displaced central venous line or arterial line
Vent Free Days	30 days	Number of days free from mechanical ventilation
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
Pressure Ulcers	End of supine session on day 4	Number of patients with pressure ulcers
Rescue Interventions	96 hours	Patients in which new initiation of inhaled pulmonary vasodilators, ECMO
ICU Free Days	30 days	Number of days not in ICU
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
Tracheostomy	30 days	Number of patients who have placement of tracheostomy
Mortality	30 days	Mortality at 30 days
S:F Ratio	96 hours	Ratio of SpO2 to FiO2

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States