Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study

Johns Hopkins University35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19 Pneumonia, Viral

Interventions

Prone PositioningOTHER

Prone Positioning

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Johns Hopkins Univeristy

Baltimore, Maryland, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

UPMC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Occurrence of an escalation in respiratory related care (yes vs no)

Participants will be assessed for the occurrence of an escalation in respiratory related care (Yes or No). Escalation in respiratory related care is clinically defined as any of the following: 1. intubation 2. any increase in flow of supplemental oxygen 3. transition to high flow nasal cannula 4. increase in fraction of inspired oxygen 5. transfer from a lower to a higher level acuity of care (e.g. medical floor to intermediate care unit (IMC) or intensive care unit (ICU); IMC to ICU).

Time frame: During hospitalization, up to 30 days

Secondary Outcomes

Oxygen Saturation

Oxygen Saturation measured in percent oxygen over a 24-hour period.

Time frame: Over a consecutive 24-hour period after randomization

Respiratory Effort as assessed by Respiratory Rate

Respiratory effort will be assessed using the respiratory rate (in breaths per minute) over a 24-hour period.

Time frame: Over a consecutive 24-hour period after randomization

Data from ClinicalTrials.gov

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