Awake Prone Positioning in Moderate to Severe COVID-19

Sponsor

Oxford University Clinical Research Unit, Vietnam (Other)

Overall Status

Recruiting

CT.gov ID

NCT05083130

Collaborator

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam (Other)

600

Enrollment

Location

Arms

19.8

Anticipated Duration (Months)

30.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 SARS-CoV2 Infection COVID-19 Acute Respiratory Distress Syndrome Acute Hypoxemic Respiratory Failure Respiratory Distress Syndrome, Adult	Behavioral: a wake prone positioning	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open label randomised controlled trial comparing standard care to prone positionOpen label randomised controlled trial comparing standard care to prone position

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 8, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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