Recruiting

ePRONEProne Positioning in ARDS for Mortality Reduction

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What is being tested

Daily prone position sessions

+ Prolonged prone position sessions

Procedure
Who is being recruted

Lung Diseases+2

+ Respiration Disorders

+ Respiratory Distress Syndrome

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorPontificia Universidad Catolica de Chile
Study ContactAlejandro Bruhn, MD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 7, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on patients suffering from Acute Respiratory Distress Syndrome (ARDS), which is a serious lung condition with a high risk of death. The study aims to determine if keeping patients in a prone position (lying face down) continuously for longer periods can reduce mortality compared to the standard practice of daily prone sessions. The prone position is known to improve lung function and reduce the harm caused by mechanical ventilation. This study is particularly important for patients who require mechanical breathing support and have severe ARDS, as finding the best prone position technique could improve survival rates. The trial involves two groups of patients, randomly assigned to either continuous or intermittent prone positioning. Those in the continuous group stay in the prone position for at least 48 hours, up to a maximum of 120 hours, while those in the intermittent group follow the current standard of 16 to 24 hours per day. This approach allows researchers to compare the effects on survival rates and any potential side effects of each method. The goal is to see which method helps keep oxygen levels stable and reduces the chances of complications over a period of seven days. The outcome of this study could lead to improved treatment strategies for those with severe ARDS.

Official TitleEffect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial
NCT06854627
Principal SponsorPontificia Universidad Catolica de Chile
Study ContactAlejandro Bruhn, MD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

780 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesRespiration DisordersRespiratory Distress SyndromeRespiratory InsufficiencyRespiratory Tract Diseases

Criteria

4 inclusion criteria required to participate
Age ≥ 18 years

Endotracheal intubation and mechanical ventilation for less than 72 hours

Moderate-severe ARDS defined as: 1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms 2. Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules 3. Respiratory failure not fully explained by cardiac failure or fluid overload 4. 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

5 exclusion criteria prevent from participating
Known pregnancy

Contraindications for prone positioning such as intracranial pressure \> 20 mmHg, massive hemoptysis, recent tracheal surgery or sternotomy or abdominal surgery with an open wound, recent facial trauma or facial surgery, unstable spine, femur, or pelvic fractures, or a single anterior chest tube with air leaks

Patient on extracorporeal membrane oxygenation (ECMO) before randomization

Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation (NIV)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
This arm will receive prone position sessions as applied in the PROSEVA trial (Guerin 2013)

Group II

Experimental
This arm will receive prone position sessions as applied in a previous multicenter study during the COVID-19 pandemics (Cornejo 2022)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

Hospital Guillermo Grant Benavente

Concepción, ChileOpen Hospital Guillermo Grant Benavente in Google Maps
Recruiting

Complejo Asistencial Dr. Victor Ríos Ruiz

Los Ángeles, Chile
Recruiting

Hospital de Quilpué

Quilpué, Chile
Recruiting

Clínica Las Condes

Santiago, Chile
Recruiting
6 Study Centers