Awake Prone Positioning in Moderate to Severe COVID-19

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Adult; Acute Hypoxemic Respiratory Failure; SARS-CoV2 Infection; COVID-19; COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Behavioral: a wake prone positioning

• Registration Number: NCT05083130
• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam

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.

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 Timeline

• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-17
• Study First Posted: 2021-10-19
• Study Start: 2022-03-08
• Primary Completion: 2023-03-31
• Study Completion: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prone position	a wake prone positioning	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

Primary Outcome Measures

Name	Time	Method
Percentage of participants who require escalation of respiratory therapy	Up to 28 days after enrollment	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

Secondary Outcome Measures

Name	Time	Method
Improvement in oxygen related parameters	Up to 28 days after enrollment	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
Fatal event	Up to 28 days after enrollment	all-cause of death within first 28 days will be compared between groups
Duration of hospital stay	Up to 2 months after enrollment	Days since admission to discharge
Number of adverse events	Up to 28 days after enrollment	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)

Trial Locations

Locations (1)

Hospital for Tropical Diseases; 🇻🇳 Ho Chi Minh City, Vietnam