Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06854627

Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS

Led by Pontificia Universidad Catolica de Chile · Updated on 2025-12-02

780

Participants Needed

6

Research Sites

142 weeks

Total Duration

On this page

Sponsors

P

Pontificia Universidad Catolica de Chile

Lead Sponsor

H

Hospital do Coracao

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Endotracheal intubation and mechanical ventilation for less than 72 hours
  • Moderate to severe ARDS defined by:
    1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms
    2. Bilateral lung infiltrates not explained by other causes
    3. Respiratory failure not due to heart failure or fluid overload
    4. PaO2/FiO2 ratio less than 150 mmHg in supine position
  • Prone positioning indicated by the attending physician or started within the last 16 hours
Not Eligible

You will not qualify if you...

  • Contraindications to prone positioning such as intracranial pressure above 20 mmHg, massive bleeding in the lungs, recent tracheal, sternotomy or abdominal surgery with an open wound, recent facial trauma or surgery, unstable spine or fractures, or a single anterior chest tube with air leaks
  • Receiving extracorporeal membrane oxygenation (ECMO) before randomization
  • Chronic respiratory failure needing oxygen therapy or non-invasive ventilation
  • Known pregnancy
  • Expected withdrawal of life support or switch to palliative care

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Hospital Guillermo Grant Benavente

Concepción, Chile

Actively Recruiting

2

Complejo Asistencial Dr. Victor Ríos Ruiz

Los Ángeles, Chile

Actively Recruiting

3

Hospital de Quilpué

Quilpué, Chile

Actively Recruiting

4

Clínica Las Condes

Santiago, Chile

Actively Recruiting

5

Hospital Clínico UC Christus

Santiago, Chile

Actively Recruiting

6

Hospital Clínico Universidad de Chile

Santiago, Chile

Actively Recruiting

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Research Team

A

Alejandro Bruhn, MD, PhD

CONTACT

E

Eduardo Kattan, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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