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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Viral; Covid19
• Intervention / Treatment: Other: Prone Positioning

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Univeristy
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control - Usual Care; Usual Care
Experimental: Intervention - Prone Positioning; Prone Positioning	Other: Prone Positioning; Prone Positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: intubation; any increase in flow of supplemental oxygen; transition to high flow nasal cannula; increase in fraction of inspired oxygen; 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).	During hospitalization, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation	Oxygen Saturation measured in percent oxygen over a 24-hour period.	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.	Over a consecutive 24-hour period after randomization

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: University of Miami; University of Pittsburgh; Duke University; Smith & Nephew, Inc.; University of North Carolina; Nox Medical Iceland
• Investigators: Principal Investigator: Naresh Punjabi, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: COVID; pneumonia; covid19; prone positioning
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; COVID-19; Pneumonia; Pneumonia, Viral
• Other Study ID Numbers: IRB00249663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No