Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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There is one clinical trial.
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.
Description: Number of participants needing mechanical ventilation over total number of participants per arm.
Measure: Incidence of Mechanical Ventilation Time: 72 hoursDescription: Percentage of time participants stay in the assigned position will be used to determine adherence.
Measure: Percentage of time in the assigned position Time: 72 hoursDescription: Number of participants with supplemental oxygen requirements.
Measure: Number of participants with supplemental oxygen requirements Time: 72 hoursDescription: Mean oxyhemoglobin saturation (percentage) measured over a 24-hour period.
Measure: Change in mean oxyhemoglobin saturation Time: At 24, 48 and 72 hoursDescription: Mean oxyhemoglobin saturation (percentage) measured over an 8-hour period (between 10pm and 6am).
Measure: Change in Nocturnal Oxyhemoglobin saturation Time: Measured between 10pm and 6am daily, up to 72 hoursDescription: Heart Rate (beats per minute) on Routine Vital Sign Assessment.
Measure: Change in Heart Rate Time: At 10, 24, 48 and 72 hoursDescription: Respiratory Rate (cycles per minute) on Routine Vital Sign Assessment.
Measure: Change in Respiratory Rate Time: At 10, 24, 48 and 72 hoursDescription: Mean oxyhemoglobin saturation (percentage) during final 7 minutes in a position.
Measure: Acute change in oxyhemoglobin saturation Time: During the final 7 minutes at each position, up to 72 hours