Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547283
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2020-09-09
Brief Title:
Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Awake-Prone Positioning Strategy for Hypoxic Patients With COVID-19 A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None