Awake Prone Positioning in Moderate to Severe COVID-19

NCT05083130 | Completed DMC

• 1 other identifier: 06NV
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; SARS-CoV2 Infection; COVID-19 Acute Respiratory Distress Syndrome; Acute Hypoxemic Respiratory Failure; Respiratory Distress Syndrome, Adult

Keywords

prone position; severe COVID-19; acute respiratory distress syndrome (ARDS); Vietnam

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fatal event

  Up to 28 days after enrollment

• Duration of hospital stay

  Up to 2 months after enrollment

• Improvement in oxygen related parameters

  Up to 28 days after enrollment

• Number of adverse events

  Up to 28 days after enrollment

Study Arms (2)

standard care

NO INTERVENTION

Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites

prone position

EXPERIMENTAL

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

Interventions

a wake prone positioning BEHAVIORAL

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.

prone position

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator

Study Sites (1)

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Location

Related Publications (4)

• 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.

  PMID: 32319424 BACKGROUND

• 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.

  PMID: 34301802 BACKGROUND

• 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

• Phong NT, Duc DH, Hai HB, Nguyen NT, Khoa LDV, Khanh LTT, Tran LHB, Linh NTM, Van CTC, Thao DP, Trinh NTD, Kieu PT, Truong NT, Hoang VT, Ngoc NT, Vien TTD, Ly VT, Khoa TD, Beane A, Anibal J; OUCRU COVID RESEACH GROUP; Thwaites GE, Geskus R, Clifton D, Dung NTP, Kestelyn E, Glover G, Tan LV, Yen LM, Tung NLN, Dung NT, Thwaites CL. Awake prone positioning effectiveness in moderate to severe COVID-19 a randomized controlled trial. Wellcome Open Res. 2024 Dec 7;9:543. doi: 10.12688/wellcomeopenres.22792.2. eCollection 2024.

  PMID: 39654551 DERIVED

Related 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 \[Internet\]

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Louise C Thwaites, MD. PhD.

  University of Oxford, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label randomised controlled trial comparing standard care to prone position

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 19, 2021
• Study Start: March 8, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

VN (1)