Covid19 Clinical Trial
Official title:
Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study
Verified date | March 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.
Status | Completed |
Enrollment | 52 |
Est. completion date | March 20, 2021 |
Est. primary completion date | March 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: Positive COVID test Endotracheal Intubation P:F <150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU. Exclusion Criteria: Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for >48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration in Prone Position | Time spent in the prone position of hours eligible for prone positioning | 96 hours | |
Secondary | Change in P:F Ratio | Change in PaO2 on ABG to FiO2 ratio from immediately prior to initiation of prone positioning to end of study period | End of supine session on day 4 | |
Secondary | Change in Drive Pressure | Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period | End of supine session on day 4 | |
Secondary | Unplanned Extubations | Number of unplanned extubations | End of supine session on day 4 | |
Secondary | Pressure Ulcers | Number of patients with pressure ulcers | End of supine session on day 4 | |
Secondary | Line Displacement | Number of displaced central venous line or arterial line | End of supine session on day 4 | |
Secondary | Vent Free Days | Number of days free from mechanical ventilation | 30 days | |
Secondary | Mortality | Mortality at 30 days | 30 days | |
Secondary | Rescue Interventions | Patients in which new initiation of inhaled pulmonary vasodilators, ECMO | 96 hours | |
Secondary | Tracheostomy | Number of patients who have placement of tracheostomy | 30 days | |
Secondary | ICU Free Days | Number of days not in ICU | 30 days | |
Secondary | S:F Ratio | Ratio of SpO2 to FiO2 | 96 hours |
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