Acute Hypoxemic Respiratory Failure, ARDS, Covid19
Conditions
Brief summary
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.
Interventions
OTHERProlonged 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
OTHERTraditional 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
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration in Prone Position | 96 hours | Time spent in the prone position of hours eligible for prone positioning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Drive Pressure | End of supine session on day 4 | Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period |
| Unplanned Extubations | End of supine session on day 4 | Number of unplanned extubations |
| Pressure Ulcers | End of supine session on day 4 | Number of patients with pressure ulcers |
| Line Displacement | End of supine session on day 4 | Number of displaced central venous line or arterial line |
| Vent Free Days | 30 days | Number of days free from mechanical ventilation |
| Change in P:F Ratio | End of supine session on day 4 | Change in PaO2 on ABG to FiO2 ratio from immediately prior to initiation of prone positioning to end of study period |
| Rescue Interventions | 96 hours | Patients in which new initiation of inhaled pulmonary vasodilators, ECMO |
| Tracheostomy | 30 days | Number of patients who have placement of tracheostomy |
| ICU Free Days | 30 days | Number of days not in ICU |
| S:F Ratio | 96 hours | Ratio of SpO2 to FiO2 |
| Mortality | 30 days | Mortality at 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Prolonged Proning Arm | Traditional Proning Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 14 | 62 years STANDARD_DEVIATION 12 | 63 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 26 | 15 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Duration in Prone Position
Time spent in the prone position of hours eligible for prone positioning
Time frame: 96 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Proning Arm | Duration in Prone Position | 56.6 hours | Standard Deviation 20.6 |
| Traditional Proning Arm | Duration in Prone Position | 45.7 hours | Standard Deviation 20.8 |
Secondary
Change in Drive Pressure
Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period
Time frame: End of supine session on day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Proning Arm | Change in Drive Pressure | 0.16 cm H20 | Standard Deviation 3.26 |
| Traditional Proning Arm | Change in Drive Pressure | 0.88 cm H20 | Standard Deviation 4.95 |
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
Time frame: End of supine session on day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Proning Arm | Change in P:F Ratio | 46.6 Ratio | Standard Deviation 39.9 |
| Traditional Proning Arm | Change in P:F Ratio | 44.3 Ratio | Standard Deviation 63.7 |
Secondary
ICU Free Days
Number of days not in ICU
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Proning Arm | ICU Free Days | 4.35 days | Standard Deviation 7.14 |
| Traditional Proning Arm | ICU Free Days | 4.15 days | Standard Deviation 7.52 |
Secondary
Line Displacement
Number of displaced central venous line or arterial line
Time frame: End of supine session on day 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prolonged Proning Arm | Line Displacement | 0 Central Venous or Arterial LineDislodged |
| Traditional Proning Arm | Line Displacement | 1 Central Venous or Arterial LineDislodged |
Secondary
Mortality
Mortality at 30 days
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged Proning Arm | Mortality | 14 Participants |
| Traditional Proning Arm | Mortality | 15 Participants |
Secondary
Pressure Ulcers
Number of patients with pressure ulcers
Time frame: End of supine session on day 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged Proning Arm | Pressure Ulcers | 1 Participants |
| Traditional Proning Arm | Pressure Ulcers | 0 Participants |
Secondary
Rescue Interventions
Patients in which new initiation of inhaled pulmonary vasodilators, ECMO
Time frame: 96 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged Proning Arm | Rescue Interventions | 0 Participants |
| Traditional Proning Arm | Rescue Interventions | 1 Participants |
Secondary
S:F Ratio
Ratio of SpO2 to FiO2
Time frame: 96 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Proning Arm | S:F Ratio | 1.70 Ratio | Standard Deviation 0.48 |
| Traditional Proning Arm | S:F Ratio | 1.69 Ratio | Standard Deviation 0.52 |
Secondary
Tracheostomy
Number of patients who have placement of tracheostomy
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged Proning Arm | Tracheostomy | 6 Participants |
| Traditional Proning Arm | Tracheostomy | 3 Participants |
Secondary
Unplanned Extubations
Number of unplanned extubations
Time frame: End of supine session on day 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prolonged Proning Arm | Unplanned Extubations | 0 Unplanned Extubations |
| Traditional Proning Arm | Unplanned Extubations | 1 Unplanned Extubations |
Secondary
Vent Free Days
Number of days free from mechanical ventilation
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Proning Arm | Vent Free Days | 6.27 days | Standard Deviation 9.15 |
| Traditional Proning Arm | Vent Free Days | 5.81 days | Standard Deviation 9.28 |