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

Covid19 Clinical Trial

— PRONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517123
• Other study ID #: IRB00249663
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pneumonia
• Pneumonia, Viral

Intervention

Other:
• Prone Positioning
Prone Positioning

Locations

Country	Name	City	State
United States	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

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oxygen Saturation	Oxygen Saturation measured in percent oxygen over a 24-hour period.	Over a consecutive 24-hour period after randomization
Secondary	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