Proning Early in Awake COVID-19 Hypoxic Respiratory Failure (PREACHR) Study
NCT ID: NCT05130541
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
219 participants
INTERVENTIONAL
2020-06-01
2021-05-01
Brief Summary
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Detailed Description
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A crucial decision point in the treatment of patients with COVID-19 in the Emergency Department is the decision to admit to the hospital for further treatment, or discharge the moderately symptomatic (hypoxic and feel ill) but not critically ill patients. However, patients who present with initially mild to moderate symptoms may progress to severe disease. There is, therefore, an unmet need to identify interventions that prevent progression to critical illness in moderately symptomatic patients.
Anecdotal reports from Emergency Physicians suggest that alternating prone and supine positioning (i.e. instructing the patient to periodically turn over) improves hypoxia and delays intubation. Dubbed proning, this technique improves hypoxia in 6-7 out of 10 intubated patients with severe acute respiratory distress syndrome (ARDS). Alternating supine and prone positioning improves the recruitment of alveoli, improves ventilation-perfusion matching, increases end-expiratory lung volumes, and improves pulmonary lymphatic drainage.
This proposal is innovative because it studies the extension of an intervention previously restricted to patients in the intensive care units with severe acute respiratory distress syndrome (ARDS). Current literature on proning in awake patients with ARDS is limited to retrospective studies with no randomized controlled trials. Further, no clinical trials to date have explored the benefits of early awake proning in COVID-19.
The development of a treatment that prevents disease progression and hospitalization in patients moderately ill with COVID-19 would decrease morbidity and mortality from COVID-19 as well as decrease the utilization of scarce healthcare resources. In addition, this trial would be the first randomized controlled-trial, contributing significantly to the nascent evidence base on treatment for COVID-19.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Usual Care
Supportive Care
Usual Care
Proning
Proning, rotating 90 degrees on long axis every 30 minutes - 2 hours
Proning
Rotating on long axis 90 degrees every 30 minutes
Supportive Care
Usual Care
Interventions
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Proning
Rotating on long axis 90 degrees every 30 minutes
Supportive Care
Usual Care
Eligibility Criteria
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Inclusion Criteria
* Presenting to the ED with symptoms suggestive of COVID-19
* Assessed by ED attending physician to not require emergent intubation
* Normal mental status and ability to communicate symptoms/distress
* Able to follow instructions independently
Exclusion Criteria
* Unable to follow verbal instructions
* Unable to communicate their needs, symptoms, or distress
* Inability to tolerate prone positioning due to mental status or habitus
18 Years
ALL
No
Sponsors
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New York Hospital Queens
OTHER
Responsible Party
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Michael Chary
Instructor
Principal Investigators
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Richard Shin, MD
Role: PRINCIPAL_INVESTIGATOR
NYP Queens
Locations
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New York Presbyterian Queens
Flushing, New York, United States
Countries
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Other Identifiers
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12910420
Identifier Type: -
Identifier Source: org_study_id