Clinical trial NCT05083130: Awake Prone Positioning in Moderate to Severe COVID-19
Official title: Evaluation of Awake Prone Positioning Effectiveness in Moderate to Severe COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
SARS-CoV2 Infection
COVID-19 Acute Respiratory Distress Syndrome
Acute Hypoxemic Respiratory Failure
Respiratory Distress Syndrome, Adult
Keywords: prone position
severe COVID-19
acute respiratory distress syndrome (ARDS)
Vietnam
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
First posted: 2021-10-19
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomised controlled trial comparing standard care to prone position
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants who require escalation of respiratory therapy
timeFrame: Up to 28 days after enrollment
Secondary outcomes:
measure: Fatal event
timeFrame: Up to 28 days after enrollment
measure: Duration of hospital stay
timeFrame: Up to 2 months after enrollment
measure: Improvement in oxygen related parameters
timeFrame: Up to 28 days after enrollment
measure: Number of adverse events
timeFrame: Up to 28 days after enrollment
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Hospital for Tropical Diseases
Study officials:
affiliation: University of Oxford, UK
name: Louise C Thwaites, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dondorp AM, Hayat M, Aryal D, Beane A, Schultz MJ. Respiratory Support in COVID-19 Patients, with a Focus on Resource-Limited Settings. Am J Trop Med Hyg. 2020 Jun;102(6):1191-1197. doi: 10.4269/ajtmh.20-0283.
citation: Gonzalez-Seguel F, Pinto-Concha JJ, Aranis N, Leppe J. Adverse Events of Prone Positioning in Mechanically Ventilated Adults With ARDS. Respir Care. 2021 Dec;66(12):1898-1911. doi: 10.4187/respcare.09194. Epub 2021 Jul 23.
citation: Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.