Clinical trial NCT04517123: Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
Official title: Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Pneumonia, Viral
Keywords: covid19
pneumonia
prone positioning
COVID
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Duke University
name: University of North Carolina
name: University of Miami
name: University of Pittsburgh
name: Smith & Nephew, Inc.
name: Nox Medical Iceland
First posted: 2020-08-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to determine whether a positional maneuver (e.g., prone positioning) decreases the need for escalation of respiratory-related care in patients with coronavirus (COVID-19) pneumonia.

Detailed description: As the initial outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease 2019 (COVID-19) has spread beyond Wuhan, China it has become a pandemic affecting over 178 countries. Of patients admitted to the ICU, upwards of 85% developed the acute respiratory distress syndrome (ARDS) and most if not all required mechanical ventilation. The beneficial effects of prone positioning for ARDS have been well described. Coupling the reported benefits of prone positioning in COVID-19 associated ARDS patients with the known beneficial effects of early prone-positioning in the treatment of ARDS, it is not surprising that many hospital systems are advocating prone positioning for treatment of ARDS in patients with COVID-19. However, as the pandemic continues to progress in the United States and the number of new cases grows as new clusters emerge, the possibility of 'rationing' ventilators becomes more real. Therefore, therapies that prevent the need for mechanical ventilation are desperately needed. Given the distinct benefit that patients with COVID-19 have with prone positioning, the overarching hypothesis of this trial is that patients with high risk for respiratory failure may also benefit from prone positioning.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* COVID-19 positive by nasopharyngeal swab or serostatus
* Use of supplemental oxygen OR respiratory rate ≥ 20

Exclusion Criteria:

* BMI ≥ 45 kg/m2
* Pregnancy
* Chest tube placement
* Hemodynamic instability with mean arterial pressure \< 60 mmHg
* Thoracic or abdominal wounds
* Chest wall deformities
* Vertebral column deformities that would preclude prone positioning
* Facial trauma or surgery in the last 30 days
* Established diagnosis of interstitial lung disease
* Prior single or double lung transplant
* Surgery for spine, femur, or pelvis in the last 3 months
* Thoracic or cardiac surgery in the last 30 days
* Pacemaker placement last 7 days

Primary outcomes:
measure: Occurrence of an escalation in respiratory related care (yes vs no)
timeFrame: During hospitalization, up to 30 days
Secondary outcomes:
measure: Oxygen Saturation
timeFrame: Over a consecutive 24-hour period after randomization
measure: Respiratory Effort as assessed by Respiratory Rate
timeFrame: Over a consecutive 24-hour period after randomization
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univeristy
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Naresh Punjabi, MD
role: PRINCIPAL_INVESTIGATOR
References: