Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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: 1. Intervention arm: Any combination of prone or side position (defined as any part of the anterior chest wall being in contact with the bed) for at least 3 hours and up to 16 hours per day during wakefulness. Patients will be asked to prone on three occasions: morning, afternoon and evening. Breaks of 30-120 min are allowed in sitting position or supine each 4 hours. Bed elevation of >30 degrees will be maintained unless otherwise requested by the patient. No control or intervention is made during sleep periods. Intervention will last for up to 3 days or until the patient achieves oxygen saturations of 94-98% on room air. Oxygen delivery may be via NC, HM, HFNC or NIV. 2. Control arm: Usual care (no Prone unless asleep and assumes this position spontaneously). The patient is able to adopt their preferred natural position. The bed will be elevated >30 degrees unless requested otherwise by the patient. However prone position may be used as rescue therapy if oxygen requirements are =>15 lit/min O2 or HFNC/NIV with FiO2 =>0.6 with O2 saturation less than 90% at the discretion of the treating physician. 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: - escalation from NP/HC/NRB to HFNO or NIV or IV - escalation from HFNO or NIV to IV Several secondary outcomes will be analyzed as well as outlined in outcomes section. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04853979
Study type Interventional
Source Hamad Medical Corporation
Contact
Status Not yet recruiting
Phase N/A
Start date April 14, 2021
Completion date July 14, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04357457 - Efficacy of Intravenous Almitrine in Reducing the Need for Mechanical Ventilation in Patients With Hypoxemic Acute Respiratory Failure Due to Covid-19-related Pneumonia Phase 3
Completed NCT03282552 - High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery Patients N/A
Recruiting NCT04079465 - Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia N/A
Recruiting NCT04402879 - CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals N/A
Recruiting NCT04445246 - Inhaled Iloprost for Suspected COVID-19 Respiratory Failure Phase 2
Completed NCT03438383 - Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery N/A
Recruiting NCT04694638 - Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection N/A
Recruiting NCT03589482 - Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure N/A
Active, not recruiting NCT03174002 - Handling Oxygenation Targets in the Intensive Care Unit Phase 4
Not yet recruiting NCT04381923 - COVIDNOCHE Trial (HFNO Versus CPAP Helmet) in COVID-19 Pneumonia N/A
Recruiting NCT03872167 - Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode. N/A
Recruiting NCT04035460 - A Pilot Study Comparing Oxygen Delivery Via Helmet Interface Versus High Flow Nasal Cannula N/A
Terminated NCT04433546 - Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS). Phase 2
Recruiting NCT04750408 - NHF vs. COT in Hypoxemic Pandemic Viral Illness N/A
Recruiting NCT04468126 - Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure N/A
Recruiting NCT02056977 - PEEP Levels Selected by PEEP Titration and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure N/A
Active, not recruiting NCT04715854 - Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas N/A
Withdrawn NCT04398290 - iNOPulse for COVID-19 Phase 2
Recruiting NCT04425031 - Handling Oxygenation Targets in COVID-19 Phase 4
Active, not recruiting NCT04070053 - Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning (TheraPPP) Pathway N/A