Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure

Covid19 Clinical Trial

— PRO-CARF  

Official title:

Prone Positioning in Non-intubated Patients With Severe COVID-19: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477655
• Other study ID #: 048/20
• Status: Completed
• Phase: N/A
• Start date: May 3, 2020
• Est. completion date: January 26, 2021

Study information

• Verified date: April 2021
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Besides protective ventilation with low tidal volumes, prone positioning is a proven intervention to decrease mortality in mechanically ventilated patients with moderate-severe acute respiratory distress syndrome. However, the evidence of this strategy in awake non-intubated patients is scarce. The investigators will perform a randomized controlled trial to define if prone positioning can reduce the requirement of mechanical ventilation.

Description:

Despite ongoing trials of antivirals and immunomodulatory therapies against COVID-19, the treatment of moderate/severe disease is mainly supportive, including oxygen therapy and invasive mechanical ventilation when impending respiratory failure is established. Moreover, the associated mortality among mechanically intubated patients is overwhelmingly high. Prone position relieves the dependent lung regions from the compressive forces of the mediastinum's weight, leading to homogenization of the gas:tissue ratio between ventral and dorsal lung regions. According to a few case series, and observational non-randomized studies with small sample sizes, there is a consistent improvement in oxygenation in COVID-19 patients during prone positioning, however there are no clinical evidence that this improvement is associated with a decrease in the risk of invasive mechanical ventilation. Considering that prone positioning is a low cost, low risk and widely available therapy, more high quality evidence is needed, to determine if the benefits of prone positioning in awake patients also include a lower requirement of mechanical ventilation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: January 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients with confirmed COVID-19, and requirement of a fraction of inspired oxygen (FiO2) =30% through high-flow nasal cannula (HFNC) to maintain a capillary saturation of =90%

Exclusion Criteria:

• Less than 18 years-old

• Pregnancy

• Patients with immediate need of invasive mechanical ventilation

• Contraindications for prone positioning therapy

• Do-not-resuscitate or do-not-intubate order

• Refusal of the patient or decision maker to enroll in the study

Related Conditions & MeSH terms

• Covid19

Intervention

Procedure:
• Awake prone positioning
Patients will be asked to remain in prone position or lateral decubitus throughout the day as long as possible.
• Standard oxygen therapy
Oxygen therapy through high flow nasal cannula (HFNC). Inspired fraction of oxygen will be titrated to maintain a capillary saturation of =92%

Locations

Country	Name	City	State
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Hospital General de Occidente	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate		28 days
Secondary	Total hours of prone position at day		28 days
Secondary	Total number of prone sessions at day		28 days
Secondary	Hours of the longest prone session each day		28 days
Secondary	Change in oxygenation 1-hour after first prone session		1 hour
Secondary	Change in the ROX-index 1-hour after first prone session	The change in the Ratio of Oxygen saturation to respiratory rate (ROX-index)	1 hour
Secondary	Total days of prone positioning therapy		28 days
Secondary	Adverse effects of prone positioning therapy		28 days
Secondary	Mechanical ventilation days		28 days
Secondary	Intensive care unit length of stay		28 days
Secondary	Hospital length of stay		28 days
Secondary	Hospital mortality		28 days