Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization

NCT04368000 | Terminated

• 1 other identifier: IRB_00132123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; COVID-19

Keywords

COVID-19; Respiratory failure

Outcome Measures

Primary Outcomes (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)

  72 hours

Secondary Outcomes (9)

• 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

Study Arms (2)

Prone Positioning

EXPERIMENTAL

Behavioral: Intermittent prone positioning instructions

Usual care

ACTIVE COMPARATOR

Behavioral: Usual care positioning with no instructions

Interventions

Intermittent prone positioning instructions BEHAVIORAL

Participants will be given instructions to lie in the prone position for a duration of 1-2 hours, every 4 hours while awake.

Prone Positioning

Usual care positioning with no instructions BEHAVIORAL

Participants will not be given instructions to lie in the prone position for any duration.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Stacy A Johnson, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 29, 2020
• Study Start: April 29, 2020
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)