Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

NCT04347941 | Terminated Results

• 1 other identifier: APPROVE-CARE-2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

Conditions

ARDS, Human; Mechanical Ventilation Complication; COVID19

Outcome Measures

Primary Outcomes (1)

• The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.

  A measure of effect of awake prone positioning in patients with confirmed or suspected COVID-19 acute hypoxemic respiratory failure undergoing supplemental oxygen via high flow nasal cannular oxygen on reducing requirement for invasive mechanical ventilation or death. Outcome measure is calculated as a count of the number of patients who went onto require invasive mechanical ventilation or died up to 28 days post randomization.

  Up to 28 days post randomisation

Secondary Outcomes (9)

• Length of Time Tolerating Prone Positioning

  Daily during intervention up to 14 days post randomisation

• PaO2/FiO2 Ratio Measured Before Prone Positioning

  Immediately before intervention

• PaO2/FiO2 Ratio After 1 Hours of Prone Positioning

  During intervention

• SpO2/FiO2 Ratio Measured Before Prone Positioning

  Immediately before intervention

• SpO2/FiO2 Ratio After 1 Hour in Prone Positioning

  During Intervention

Study Arms (2)

Prone Positioning

EXPERIMENTAL

Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals

Procedure: Prone Positioning

Standard Care

ACTIVE COMPARATOR

Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.

Procedure: Standard of care.

Interventions

Prone Positioning PROCEDURE

Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 \<94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 \>94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula

Prone Positioning

Standard of care. PROCEDURE

Standard of care. Prone positioning may be administered as a rescue therapy

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or confirmed COVID19 infection
• Bilateral Infiltrates on CXR
• SpO2 \<94% on FiO2 40% by either venturi facemask or high flow nasal cannula
• RR \<40
• Written informed consent

You may not qualify if:

• Age \<18
• Uncooperative or likely to be unable to lie on abdomen for 16 hours
• Receiving comfort care only
• Multi-organ failure
• RR\>40
• Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy \>20/40 gestation, severe brain injury).

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

Galway University Hospital

Galway, Ireland

Location

Related Publications (2)

• Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.

  PMID: 34425070 BACKGROUND

• Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.

  PMID: 33177145 RESULT

Related Links

• Result of Meta-trial in which RCT was incorporated

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Interventions

Prone Position; Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Study was terminated after an interim analysis of a prospective meta-trial in which the patients reached statistical criteria for efficiency

Results Point of Contact

• Title: Dr Bairbre McNicholas
• Organization: National University of Ireland, Galway

bmcnicholas@nuigalway.ie

+35391893063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anaesthesia and Intensive Care Medicine, School of Medicine, NUI Galway

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: July 11, 2020
• Primary Completion: January 26, 2021
• Study Completion: January 26, 2021
• Last Updated: December 2, 2021
• Results First Posted: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: up to 15 years post study

Locations

IE (1)