Acute Hypoxemic Respiratory Failure, COVID-19, COVID-19 Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome, Adult, SARS-CoV2 Infection
Conditions
Keywords
prone position, severe COVID-19, acute respiratory distress syndrome (ARDS), 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.
Interventions
BEHAVIORALa 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.
Sponsors
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Oxford University Clinical Research Unit, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Open label randomised controlled trial comparing standard care to prone position
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Vietnam
Outcome results
None listed