- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05083130
Awake Prone Positioning in Moderate to Severe COVID-19
June 5, 2023 updated by: Oxford University Clinical Research Unit, Vietnam
Evaluation of Awake Prone Positioning Effectiveness 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ho Chi Minh City, Vietnam
- Hospital for Tropical Diseases
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Up to 28 days after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatal event
Time Frame: Up to 28 days after enrollment
|
all-cause of death within first 28 days will be compared between groups
|
Up to 28 days after enrollment
|
Duration of hospital stay
Time Frame: Up to 2 months after enrollment
|
Days since admission to discharge
|
Up to 2 months after enrollment
|
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
|
Up to 28 days after enrollment
|
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)
|
Up to 28 days after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Louise C Thwaites, MD. PhD., University of Oxford, UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
- Prone position in ARDS patients: why, when, how and for whom. Intensive Care Med [Internet]. 2020;46(12):2385-96.
- Prone positioning in severe acute respiratory distress syndrome. N Engl J Med [Internet]. 2013 Jun 6 [cited 2014 May 23];368(23):2159-68
- Vietnam Ministry of Health guideline on COVID-19 management, treatment
- Effect of awake prone position on diaphragmatic thickening fraction in patients assisted by noninvasive ventilation for hypoxemic acute respiratory failure related to novel coron
- Effect of early awake prone positioning application on prognosis in patients with acute respiratory failure due to COVID-19 pneumonia: a retrospective observational study. Brazilian J Anesthe
- Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care [Internet]
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2022
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
May 1, 2023
Study Registration Dates
First Submitted
October 10, 2021
First Submitted That Met QC Criteria
October 17, 2021
First Posted (Actual)
October 19, 2021
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 5, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Syndrome
- Respiratory Insufficiency
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- 06NV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymised data of this study may be requested for publication by journals.
Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected.
No identifiable information will be shared with any other person/organisation
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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