Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19

Not Applicable

Completed

• Conditions: Respiratory Failure; Covid19
• Interventions: Other: Usual Care; Other: APPS

• Registration Number: NCT04547283
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This study aims to determine if a strategy of recommending prone (on stomach) positioning of patients positive or suspected positive for coronavirus disease 2019 (COVID-19) requiring supplemental oxygen, but not mechanically ventilated, Is feasible in the inpatient setting. This study will be performed as a pragmatic pilot clinical trial to gain information relevant to the future conduct of a larger trial.

Detailed Description

Severe acute respiratory syndrome coronavirus-2, SARS-CoV-2, the virus causing coronavirus disease 2019 (COVID-19) pandemic, has rapidly led to significant morbidity and mortality worldwide, primarily through lower respiratory tract involvement progressing from hypoxemia to acute respiratory distress syndrome. Novel approaches to improving oxygenation are urgently needed to limit aerosolization concerns and resource scarcity associated with intubation and, to a lesser extent, other forms of advanced respiratory support.

Prone positioning in mechanically ventilated patients with hypoxemic respiratory failure has been associated with improvement in oxygenation and mortality in patients with acute respiratory distress syndrome (ARDS). The prone position appears to provide more uniform lung perfusion, shifting ventilation to well-perfused lung segments and recruitment of dependent atelectatic regions of lung. Physiological alterations associated with the prone position would foreseeably also apply to spontaneously breathing patients and evidence from small observational studies suggests that prone positioning in non-intubated patients is feasible associated with improvement in oxygenation. However, it remains unknown if a prone ventilation strategy is truly beneficial for non-intubated hypoxic Covid-19 patients, and this question has stimulated interest in the conduct of rigorous randomized controlled trials (RCT).

However, the awake prone strategy is a complex medical intervention with multiple implementation nuances such as adoption, feasibility, and tolerability that may affect successful conduct of a definitive RCT. In order to increase the likelihood of a successful future RCT, the investigators will conduct the APPS pilot study. The overall aim of the APPS pilot trial was to assess feasibility and important contextual factors for a large RCT to compare the clinical effectiveness of an Awake-Prone Positioning Strategy (APPS) for respiratory support versus usual care alone for hypoxic adults with Covid-19.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-06-14
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Primary Completion: 2020-09-20
• Study Completion: 2020-09-30
• Status Verified: 2021-07
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• hospitalized patients with positive COVID testing during hospitalization or 7 days prior OR Hospitalized with suspected COVID pneumonia
• room air oxygen saturation <93% or oxygen requirement > or equal to 3 Liters per minute

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Exclusion Criteria

• unable to turn self, spinal instability, facial or pelvic fractures, open chest or open abdomen, altered mental status, anticipated difficult airway, show signs of respiratory fatigue, or receiving end-of-life care

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Participants randomized to this arm will remain in their clinician's team standard practice and their natural choice of position, which is anticipated to favor a supine (rather than prone) position.
Awake-Prone Positioning Strategy	APPS	Participants randomized to this arm will receive guidance from their Inpatient treatment team to assume the prone position for as much time as is tolerable during hospitalization.

Primary Outcome Measures

Name	Time	Method
Time spent with S/F ratio < 315	48 hours from eligibility	Time spent with oxygenation saturation to fraction of inspired oxygen ratio less than 315
Average S/F ratio	48 hours from eligibility	Average oxygen saturation to fraction of inspired oxygen ratio

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	through study completion, Up to 30 days	Number of days from hospital admission to discharge
Number of patients requiring ICU admission during study period	48 hours from eligibility	Number of patients requiring ICU admission during study period
Number of patients experiencing who die prior to discharge	through study completion, Up to 30 days	Number of patients who die prior to hospital discharge
Number of patients requiring intubation	48 hours From eligibility	Number of patients requiring intubation
Highest oxygen support	48 hours from eligibility	Highest level of supplemental oxygen required
Number of patients requiring ICU admission during hospitalization	through study completion, Up to 30 days	Number of patients requiring ICU admission during hospitalization

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States