Awake Prone Positioning in Moderate to Severe COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05083130
• Other study ID #: 06NV
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Acute Lung Injury
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• SARS-CoV2 Infection
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Vietnam	Hospital for Tropical Diseases	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Country where clinical trial is conducted

Vietnam, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatal event	all-cause of death within first 28 days will be compared between groups	Up to 28 days after enrollment
Secondary	Duration of hospital stay	Days since admission to discharge	Up to 2 months after enrollment
Secondary	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
Secondary	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

External Links

•   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]
•   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