Awake Prone Positioning in Moderate to Severe COVID-19

Evaluation of Awake Prone Positioning Effectiveness in Moderate to Severe COVID-19

The purpose of this study is comparing vital signs between standard care and prone position groups. Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. For those randomized to prone position, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV2 Infection; Respiratory Distress Syndrome, Adult; Acute Hypoxemic Respiratory Failure; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Behavioral: a wake prone positioning

Detailed Description

This study is a pragmatic open label randomised controlled trial. After being informed about the study and potential risks, all patients having written informed consents will be randomised into two groups. Standard care group will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. To reduce bias, the study team will make visits at a similar schedule to those to patients in the intervention group, however these visits will be confined to general advice and measurement of vital signs. Patients will receive written advice more general in nature about COVID-19 disease. For those randomized to prone position group, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day. The team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers. Compliance with the intervention will be evaluated by observation (manual and using in-room cameras) at fixed time intervals. In a subgroup of 100 patients accelerometer/gyrometer devices will be used to measure movement and position (this will be expanded to all patients if equipment is available). Other outcome measures (SpO2, heart rate etc) will be measured using standard monitoring equipment currently used at study sites, including wearable devices.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Hospital For Tropical Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Probable or confirmed COVID-19 infection according to WHO criteria
• Moderate or severe COVID-19 respiratory infection according to Vietnamese guidelines
• Requirement for supplemental oxygen therapy

Exclusion Criteria:

• Invasive mechanical ventilation, or non-invasive ventilation (NIV) with CPAP or BiPAP or imminent need for these
• Contraindications to prone position (see Appendix 5)
• Pregnancy
• Severe obesity (BMI >35),
• Altered level of consciousness (GCS <13)
• Attending doctor judged prone position to be unsuitable for the patient for any reason
• Patients in whom there is a decision that care will not be escalated
• Failure to have informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care; Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites
Experimental: prone position; prone position group will have a special intervention team who visits patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day	Behavioral: a wake prone positioning; The team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position for at least 8 hours per day. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who require escalation of respiratory therapy	Escalation of respiratory therapy within 28 days of randomization, defined as any of the following: Escalation to next level respiratory support (with lowest level nasal cannula or face mask, escalating through HFNC to NIV or mechanical ventilation).; Intubation	Up to 28 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatal event	all-cause of death within first 28 days will be compared between groups	Up to 28 days after enrollment
Duration of hospital stay	Days since admission to discharge	Up to 2 months after enrollment
Improvement in oxygen related parameters	SpO2, respiratory rate, heart rate, FiO2, ROX index will be documented before and at end of period of prone positioning every day. The improvement will be measured by resolution of them compared with baseline parameters	Up to 28 days after enrollment
Number of adverse events	An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The severity of all AEs in this trial should be graded in line with the toxicity grading in Toxicity grading and management (CTCAE)	Up to 28 days after enrollment

Collaborators and Investigators

• Sponsor: Oxford University Clinical Research Unit, Vietnam
• Collaborators: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
• Investigators: Principal Investigator: Louise C Thwaites, MD. PhD., University of Oxford, UK

Publications and helpful links

General Publications

• 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.
• Dondorp AM, Hayat M, Aryal D, Beane A, Schultz MJ. Respiratory Support in COVID-19 Patients, with a Focus on Resource-Limited Settings. Am J Trop Med Hyg. 2020 Jun;102(6):1191-1197. doi: 10.4269/ajtmh.20-0283.
• Gonzalez-Seguel F, Pinto-Concha JJ, Aranis N, Leppe J. Adverse Events of Prone Positioning in Mechanically Ventilated Adults With ARDS. Respir Care. 2021 Dec;66(12):1898-1911. doi: 10.4187/respcare.09194. Epub 2021 Jul 23.

Helpful Links

• Prone position in ARDS patients: why, when, how and for whom. Intensive Care Med [Internet]. 2020;46(12):2385-96.
• Prone positioning in severe acute respiratory distress syndrome. N Engl J Med [Internet]. 2013 Jun 6 [cited 2014 May 23];368(23):2159-68
• Vietnam Ministry of Health guideline on COVID-19 management, treatment
• Effect of awake prone position on diaphragmatic thickening fraction in patients assisted by noninvasive ventilation for hypoxemic acute respiratory failure related to novel coron
• Effect of early awake prone positioning application on prognosis in patients with acute respiratory failure due to COVID-19 pneumonia: a retrospective observational study. Brazilian J Anesthe
• Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care [Internet]

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: October 10, 2021
• First Submitted That Met QC Criteria: October 17, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: prone position; Vietnam; acute respiratory distress syndrome (ARDS); severe COVID-19
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 06NV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No