Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Prone position (placing the patient on his abdomen) has been shown to be an effective intervention to decrease mortality in adults connected to mechanical ventilation for moderate to severe Acute Respiratory Distress Syndrome (ARDS). Patients may require one or more sessions of prone position. However, the optimal duration of prone sessions is unknown. The goal of this clinical trial is to learn if applying prone position in prolonged sessions (\> 48 hours - prolonged prone position) is more effective than applying it in daily sessions (16 to 24 hours - intermittent prone position). The trial will also learn about the safety of prolonged prone position compared to intermittent prone position. The main questions it aims to answer are: * Does prolonged prone position increase survival compared to intermittent prone position in participants with moderate to severe ARDS ? * How does prolonged prone position compare to intermittent prone position in terms of medical problems associated to prone position ? Researchers will compare prolonged versus intermittent prone position to see which approach is better to treat moderate to severe ARDS. Participants will: * Receive prone position either in prolonged (\> 48 hours) or daily (16 to 24 hours) sessions during the first 7 days * Be followed for up to 90 days to assess their clinical evolution

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Endotracheal intubation and mechanical ventilation for less than 72 hours

• Moderate-severe ARDS defined as:

‣ Within 1 week of a known clinical insult or new or worsening respiratory symptoms

⁃ Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules

⁃ Respiratory failure not fully explained by cardiac failure or fluid overload

⁃ PaO2/FiO2 \< 150 mmHg in supine position

• Prone positioning has been indicated by the attending physician, OR has already been initiated within the last 16 hours

Locations
Other Locations
Chile
Hospital Guillermo Grant Benavente
RECRUITING
Concepción
Complejo Asistencial Dr. Victor Ríos Ruiz
RECRUITING
Los Ángeles
Hospital de Quilpué
RECRUITING
Quilpué
Clínica Las Condes
RECRUITING
Santiago
Hospital Clínico UC Christus
RECRUITING
Santiago
Hospital Clínico Universidad de Chile
RECRUITING
Santiago
Contact Information
Primary
Alejandro Bruhn, MD, PhD
abruhn@uc.cl
+56223543292
Backup
Eduardo Kattan, MD, PhD
e.kattan@gmail.com
994793024
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2028-01
Participants
Target number of participants: 780
Treatments
Active_comparator: Intermittent Prone Position
This arm will receive prone position sessions as applied in the PROSEVA trial (Guerin 2013)
Experimental: Prolonged Prone Position
This arm will receive prone position sessions as applied in a previous multicenter study during the COVID-19 pandemics (Cornejo 2022)
Sponsors
Collaborators: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, Fundacion Clinica Valle del Lili, Hospital do Coracao
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov