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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368000
Recruitment Status : Terminated (Study was terminated due to lack of adherence to the protocol in the intervention arm.)
First Posted : April 29, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Stacy Johnson, University of Utah

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Respiratory Failure COVID-19 Behavioral: Intermittent prone positioning instructions Behavioral: Usual care positioning with no instructions Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization
Actual Study Start Date : April 29, 2020
Actual Primary Completion Date : August 6, 2020
Actual Study Completion Date : August 6, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Change in imputed PaO2/FiO2 from SpO2/FiO2 [ Time Frame: 48 hours ]
  2. Proportion of participants requiring endotracheal intubation [ Time Frame: Up to 8 weeks ]
  3. Proportion of participants requiring mechanical ventilation [ Time Frame: Up to 8 weeks ]
  4. Proportion of participants transferred to intensive care for worsening respiratory failure [ Time Frame: Up to 8 weeks ]
  5. Proportion of participants who had escalated oxygen delivery needs [ Time Frame: Up to 8 weeks ]
  6. Average number of days hospitalized [ Time Frame: Up to 8 weeks ]
  7. Average number of ventilator-free days [ Time Frame: Up to 8 weeks ]
  8. Proportion of participants discharged from hospital on hospice [ Time Frame: Up to 8 weeks ]
  9. Proportion of participants with all-cause inpatient mortality [ Time Frame: Up to 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368000


Locations
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United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Stacy A Johnson, MD University of Utah
More Information
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Responsible Party: Stacy Johnson, Associate Professor of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT04368000    
Other Study ID Numbers: IRB_00132123
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stacy Johnson, University of Utah:
COVID-19
Respiratory failure
Additional relevant MeSH terms:
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COVID-19
Respiratory Insufficiency
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders