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Completed

NCT Number: NCT04517123

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Univeristy, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone Positioning

Other

Prone Positioning

Primary outcomes

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

    Time frame: 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 outcomes

  1. Oxygen Saturation

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Acronym: PRONE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2020
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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