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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Covid19 Pneumonia, Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control - Usual Care

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention - Prone Positioning

Prone Positioning

Group Type EXPERIMENTAL

Prone Positioning

Intervention Type OTHER

Prone Positioning

Interventions

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Prone Positioning

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No