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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2021-03-20

Brief Summary

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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.

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Detailed Description

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Conditions

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ARDS Covid19 Acute Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Prolonged Proned Positioning

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Traditional Proning Arm

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No