Incline Positioning in COVID-19 Patients for Improvement in Oxygen Saturation
Stopped early · Not applicable
Conditions studied: COVID, Hypoxic Respiratory Failure
In brief
COVID-19 is a respiratory illness caused by SARS-CoV-2 with a range of symptoms from mild, self-limiting respiratory tract infections to severe progressive pneumonia, multiorgan dysfunction and death. A portion of individuals with COVID-19 experience life-threatening hypoxia requiring supplemental oxygen and mechanical ventilation. Management of hypoxia in this population is complicated by contraindication of non-invasive ventilation and limitations in access to mechanical ventilation and critical care staff given the clinical burden of disease. Positional therapy is readily deployable and may ultimately be used to treat COVID-19 related respiratory failure in resources limited settings; and, it has been demonstrated to improve oxygenation and is easy to implement in the clinical setting. The overall goal of this randomized controlled trial is to establish the feasibility of performing a randomized trial using a simple, minimally invasive positional therapy approach to improve hypoxia and reduce progression to mechanical ventilation. The objectives are to examine the effectiveness and feasibility of maintaining an inclined position in patients with confirmed or suspected COVID-19 associated hypoxemic respiratory failure. The investigators hypothesize that (1) oxyhemoglobin saturation will improve with therapy, (2) participants will tolerate and adhere to the intervention, and that (3) participants who adhere to positional therapy will have reduced rates of mechanical ventilation at 72 hours. If successful, this feasibility trial will demonstrate that a simple, readily deployed nocturnal postural maneuver is well tolerated and reverses underlying defects in ventilation and oxygenation due to COVID-19. It will also inform the design of a pivotal Phase III trial with estimates of sample sizes for clinically relevant outcomes.
Key facts
- Study ID
- NCT04344561
- Run by
- Johns Hopkins University
- People needed
- 7
- Starts
- 2020-05-25
- Expected to finish
- 2022-05-01
- Last updated by the study team
- 2022-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- COVID-19 positive
- Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms (cough, sputum production, or dyspnea).
- Hypoxemia defined as ≥ 2 L/min oxygen
You may not qualify if…
- Intubation
- Inability to lie supine
Where it is running
- Johns Hopkins Bayview Hospital — Baltimore, Maryland, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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