Awake Prone Positioning in Moderate to Severe COVID-19

Oxford University Clinical Research Unit, Vietnam

Status: Completed

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

Treatments: Behavioral: a wake prone positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05083130

06NV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

standard care

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: a wake prone positioning