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

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

Conditions

• Acute Respiratory Distress Syndrome

Interventions

PROCEDURE

Daily prone position sessions

Prone position sessions will be extended at least 16 hours, but no longer than 24 hours. Prone sessions will be repeated if PaO2/FiO2 ratio decreases to \< 150 after returning to supine position within the first 7 days after randomization. The extension of repeated prone sessions will follow the same criteria.

PROCEDURE

Prolonged prone position sessions

Prone position sessions will be extended at least 48 hours AND until PaO2/FiO2 ratio is ≥ 200, but no longer than 120 hours. Prone sessions will be repeated if PaO2/FiO2 ratio decreases to \< 150 after returning to supine position within the first 7 days after randomization. The extension of repeated prone sessions will follow the same criteria.

Sponsors & Collaborators

• Hospital do Coracao

  collaborator OTHER

• Fundacion Clinica Valle del Lili

  collaborator OTHER

• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

  collaborator OTHER_GOV

• Pontificia Universidad Catolica de Chile

  lead OTHER

Principal Investigators

• Alejandro Bruhn, MD, PhD · Pontificia Universidad Catolica de Chile

• Rodrigo Cornejo, MD, MBA · University of Chile

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-07

Primary Completion

2027-10-31

Completion

2028-01-31

Countries

• Argentina
• Chile
• Colombia
• Ecuador
• Mexico
• Uruguay

Study Locations