Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization

COVID-19 Clinical Trial

— PAPR  

Official title:

Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04368000
• Other study ID #: IRB_00132123
• Status: Terminated
• Phase: N/A
• Start date: April 29, 2020
• Est. completion date: August 6, 2020

Study information

• Verified date: December 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 6, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• Usual care positioning with no instructions
Participants will not be given instructions to lie in the prone position for any duration.

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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