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

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04517123
Collaborator
Duke University (Other), University of North Carolina (Other), University of Miami (Other), University of Pittsburgh (Other), Smith & Nephew, Inc. (Industry), Nox Medical Iceland (Other)
100
Enrollment
4
Locations
2
Arms
16
Anticipated Duration (Months)
25
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Prone Positioning
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prone Position and Respiratory Outcomes in Non-Intubated COVID-19 PatiEnts The "PRONE" Study
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/Treatment
No Intervention: Control - Usual Care

Usual Care

Experimental: Intervention - Prone Positioning

Prone Positioning

Other: Prone Positioning
Prone Positioning

Outcome Measures

Primary Outcome Measures

  1. Occurrence of an escalation in respiratory related care (yes vs no) [During hospitalization, up to 30 days]

    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).

Secondary Outcome Measures

  1. Oxygen Saturation [Over a consecutive 24-hour period after randomization]

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

  2. Respiratory Effort as assessed by Respiratory Rate [Over a consecutive 24-hour period after randomization]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Johns Hopkins UniveristyBaltimoreMarylandUnited States21287
2University of North CarolinaChapel HillNorth CarolinaUnited States27514
3Duke UniversityDurhamNorth CarolinaUnited States27710
4UPMCPittsburghPennsylvaniaUnited States15213

Sponsors and Collaborators

  • Johns Hopkins University
  • Duke University
  • University of North Carolina
  • University of Miami
  • University of Pittsburgh
  • Smith & Nephew, Inc.
  • Nox Medical Iceland

Investigators

  • Principal Investigator: Naresh Punjabi, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04517123
Other Study ID Numbers:
  • IRB00249663
First Posted:
Aug 18, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021