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The investigator hypothesis is that early implementation of early, awake prone position for patients with COVID-19 pneumonia requiring oxygen therapy will reduce the need for escalation of respiratory support. Escalation of respiratory support is defined as the need for respiratory support with HFNO, NIV or IV.
The world health organization has designated the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) as an ongoing pandemic and a public health emergency of international concern. The disease is estimated to be severe in 20% of patients and about 5-10% will need critical care with respiratory support. ARDS is thought to be the main cause of respiratory failure in COVID-19 patients. Research is still ongoing to further elucidate the different ARDS subtypes that may exist in COVID-19. It is crucial to find new targets for treatment and support of COVID-19 patients with respiratory failure.
Prone positioning causes a substantial improvement in oxygenation that appear to persist after the patient is returned to a supine position. It has also been shown to have a significant mortality benefit in invasively ventilated ARDS patients. Observational studies have shown improvement in oxygenation with awake prone positioning in non-intubated patients with COVID-19 pneumonia. There is no published RCTs to date. It remains unclear whether prone positioning averts invasive or non-invasive ventilation, accelerates recovery, or reduces mortality. Similarly, there is no data on presumed viral pneumonia. Future studies are needed to identify the optimal indications for, duration of pronation, and assessment of response.
Hypothesis: The investigator hypothesis is that early implementation of early, awake pronation for patients with Covid19 pneumonia requiring oxygen therapy will reduce the need for escalation of respiratory support. Escalation of respiratory support is defined as the need for respiratory support with HFNO, NIV or IV Research participants: Adults 18 years and older with suspected or confirmed COVID-19 presenting to HMC with hypoxemic respiratory failure (PF<200 or SpO2 less than 94% on FiO2>=0.4 or =>5 lit/min O2)
Design: This is a non-blinded randomized controlled trial. Participants will be randomized to one of two study arms:
Methods and outcomes:
Data will be analyzed for escalation of respiratory support within the first three days of the study. Escalation of respiratory support is defined as follows:
Based on previous studies of prone position in COVID-19 patients, anticipate an improvement in oxygenation and possible prevention of intubation with shorter mechanical ventilation times. Awake proning has been shown to be safe in local practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRONE | Experimental | Any combination of prone or side position for 3 hours, 3 times a day for 3 days. |
|
| NO PRONE | Active Comparator | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRONE POSITION | Other | Any combination of prone or side position for 3 hours, 3 times a day for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients requiring escalation to NIV (CPAP or BIPAP) or IV in each group | To assess the potential for prone position to reduce the requirement for escalation of respiratory support. | 30 days |
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Inclusion Criteria: - All adults with suspected or confirmed COVID-19 and hypoxemia respiratory failure.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | 3050 | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38689829 | Derived | Harris TRE, Bhutta ZA, Qureshi I, Kharma N, Raza T, Hssain AA, Pathare AS, D'Silva A, Khatib MY, Mohamedali MGH, Macineira IMG, Garcia Hernandez VR, Garcia JR, Thomas SH, Pathan SA. A randomised clinical trial of awake prone positioning in COVID-19 suspects with acute hypoxemic respiratory failure. Contemp Clin Trials Commun. 2024 Apr 13;39:101295. doi: 10.1016/j.conctc.2024.101295. eCollection 2024 Jun. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Prone position cannot be masked to any member in the trial
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