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

Purpose

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.

Conditions

  • ARDS
  • Covid19
  • Acute Hypoxemic Respiratory Failure

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04581811
Status
Completed
Sponsor
University of Alabama at Birmingham