Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)

Covid19 Clinical Trial

Official title:

Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581811
• Other study ID #: IRB-300005979
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: March 20, 2021

Study information

• Verified date: March 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Acute Lung Injury
• ARDS
• COVID-19
• Covid19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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