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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Proning Arm | Experimental | Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study |
|
| Traditional Proning Arm | Active Comparator | Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Proned Positioning | Other | Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period |
| Measure | Description | Time Frame |
|---|---|---|
| Duration in Prone Position | Time spent in the prone position of hours eligible for prone positioning | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Drive Pressure |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34491885 | Derived | Page DB, Vijaykumar K, Russell DW, Gandotra S, Chiles JW, Whitson MR, Dransfield MT. Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome: A Randomized Pilot Clinical Trial. Ann Am Thorac Soc. 2022 Apr;19(4):685-687. doi: 10.1513/AnnalsATS.202104-498RL. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prolonged Proning Arm | Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study Prolonged Proned Positioning: Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period |
| FG001 | Traditional Proning Arm | Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study Traditional Proning Arm: Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prolonged Proning Arm | Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study Prolonged Proned Positioning: Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration in Prone Position | Time spent in the prone position of hours eligible for prone positioning | Posted | Mean | Standard Deviation | hours | 96 hours |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prolonged Proning Arm | Patients will receive 24 hours in the prone position followed by up to 8 hours in the supine position for the duration of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Page - PI | UAB Hospital | 205-975-7387 | dpage1@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2020 | Mar 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Traditional Proning Arm | Other | Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period |
|
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 |
| Unplanned Extubations | Number of unplanned extubations | End of supine session on day 4 |
| Pressure Ulcers | Number of patients with pressure ulcers | End of supine session on day 4 |
| Line Displacement | Number of displaced central venous line or arterial line | End of supine session on day 4 |
| Vent Free Days | Number of days free from mechanical ventilation | 30 days |
| Mortality | Mortality at 30 days | 30 days |
| Rescue Interventions | Patients in which new initiation of inhaled pulmonary vasodilators, ECMO | 96 hours |
| Tracheostomy | Number of patients who have placement of tracheostomy | 30 days |
| ICU Free Days | Number of days not in ICU | 30 days |
| S:F Ratio | Ratio of SpO2 to FiO2 | 96 hours |
| Traditional Proning Arm |
Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study Traditional Proning Arm: Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | Ratio | 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 | Posted | Mean | Standard Deviation | cm H20 | End of supine session on day 4 |
|
|
|
| Secondary | Unplanned Extubations | Number of unplanned extubations | Posted | Number | Unplanned Extubations | End of supine session on day 4 |
|
|
|
| Secondary | Pressure Ulcers | Number of patients with pressure ulcers | Posted | Count of Participants | Participants | End of supine session on day 4 |
|
|
|
| Secondary | Line Displacement | Number of displaced central venous line or arterial line | Posted | Number | Central Venous or Arterial LineDislodged | End of supine session on day 4 |
|
|
|
| Secondary | Vent Free Days | Number of days free from mechanical ventilation | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| Secondary | Mortality | Mortality at 30 days | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Rescue Interventions | Patients in which new initiation of inhaled pulmonary vasodilators, ECMO | Posted | Count of Participants | Participants | 96 hours |
|
|
|
| Secondary | Tracheostomy | Number of patients who have placement of tracheostomy | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | ICU Free Days | Number of days not in ICU | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| Secondary | S:F Ratio | Ratio of SpO2 to FiO2 | Posted | Mean | Standard Deviation | Ratio | 96 hours |
|
|
|
| 14 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Traditional Proning Arm | Patients will receive standard 16 hour prone positioning followed by up to 8 hours in the supine position for the duration of the study | 15 | 26 | 0 | 26 | 0 | 26 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |