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NCT Number: NCT05083130

Awake Prone Positioning in Moderate to Severe COVID-19

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.

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Key information

Conditions

COVID-19 Acute Hypoxemic Respiratory Failure COVID-19 Acute Respiratory Distress Syndrome Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a wake prone positioning

Behavioral

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.

Primary outcomes

  1. Percentage of participants who require escalation of respiratory therapy

    Time frame: 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 outcomes

  1. Fatal event

    Time frame: Up to 28 days after enrollment

    all-cause of death within first 28 days will be compared between groups

  2. Duration of hospital stay

    Time frame: Up to 2 months after enrollment

    Days since admission to discharge

  3. Improvement in oxygen related parameters

    Time frame: 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

  4. Number of adverse events

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2021
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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