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

The University of Alabama at Birmingham

Status: Completed

Conditions: Acute Hypoxemic Respiratory Failure; Covid19; ARDS

Treatments: Other: Prolonged Proned Positioning; Other: Traditional Proning Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04581811

IRB-300005979

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Prolonged Proning Arm

Experimental 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

Treatment:

Other: Prolonged Proned Positioning

Traditional Proning Arm

Active Comparator group

Description:

Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study

Treatment:

Other: Traditional Proning Arm