Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization (PAPR)

Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes.

Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

Study Overview

• Status: Terminated
• Conditions: COVID-19; Respiratory Failure
• Intervention / Treatment: Behavioral: Intermittent prone positioning instructions; Behavioral: Usual care positioning with no instructions

Detailed Description

In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) is mild in 81% of patients, severe disease occurs in 14%, and 5% of cases result in critical illness. The reported overall case fatality rate (CFR) is 2.3% in China, although the CFR varies widely (0.7- 7.2%) between regions. Older age is associate with increased mortality. The reported CFR is 8% among patients 70-79 years old and 15% in those 80 years and older.

Multiple therapies have been proposed based on in vitro evidence or anecdotal reports. Although, no high quality clinical trials have demonstrated an effective treatment regimen other than supportive care. Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes.

Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. Improvements in gas exchange, cardiac output, and clearance of secretions have been demonstrated with PP, and are thought to contribute to the survival benefits. Low quality evidence from case series and retrospective studies in awake, spontaneously breathing patients suggest PP is feasible, improves oxygenation, and may avoid the need for mechanical ventilation. A recent prospective observational study of early PP combined with high-flow nasal cannula or non-invasive mechanical ventilation was well tolerated and may help patients avoid intubation.

This study is a single-center non-blinded randomized controlled pragmatic feasibility study comparing the outcomes of prone positioning (intervention) versus usual care (control) in non-intubated patients hospitalized for COVID-19.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult (age ≥ 18 years)
• Suspected or Confirmed COVID-19 (Suspected: High clinical suspicion AND pending COVID-19 assay; Confirmed: Positive COVID-19 assay within 10 days)
• Scheduled for admission or already admitted to an inpatient hospital bed
• Patients must be enrolled within 48 hours of hospital admission

Exclusion Criteria:

• Pregnant
• Prisoner
• Contraindication to prone positioning: known increased intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mm Hg, increased abdominal pressure or risk for abdominal compartment syndrome, massive hemoptysis requiring urgent intervention, tracheal surgery or sternotomy during previous 14 days, facial surgery or serious facial trauma within 14 days, pacemaker implantation within 48 hours, unstable spine, femur, or pelvic fractures, chest tube, mean arterial pressure less than 65 mm Hg
• Lung transplant
• Burns on more than 20% of body surface
• Chronic respiratory failure requiring: mechanical ventilation via endotracheal device (e.g. tracheostomy tube, orotracheal tube, or nasotracheal tube)
• Inability to change position from supine to prone and prone to supine without assistance
• Receiving end of life care, comfort measures only, or hospice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Usual care	Behavioral: Usual care positioning with no instructions; Participants will not be given instructions to lie in the prone position for any duration.
EXPERIMENTAL: Prone Positioning	Behavioral: Intermittent prone positioning instructions; Participants will be given instructions to lie in the prone position for a duration of 1-2 hours, every 4 hours while awake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in imputed partial pressure of oxygen over fraction of inspired oxygen (PaO2/FiO2) from peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in imputed PaO2/FiO2 from SpO2/FiO2	48 hours
Proportion of participants requiring endotracheal intubation	Up to 8 weeks
Proportion of participants requiring mechanical ventilation	Up to 8 weeks
Proportion of participants transferred to intensive care for worsening respiratory failure	Up to 8 weeks
Proportion of participants who had escalated oxygen delivery needs	Up to 8 weeks
Average number of days hospitalized	Up to 8 weeks
Average number of ventilator-free days	Up to 8 weeks
Proportion of participants discharged from hospital on hospice	Up to 8 weeks
Proportion of participants with all-cause inpatient mortality	Up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Stacy A Johnson, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2020
• Primary Completion (ACTUAL): August 6, 2020
• Study Completion (ACTUAL): August 6, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Respiratory failure
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency
• Other Study ID Numbers: IRB_00132123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No