Comparing prolonged and daily prone positioning for ARDS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of prolonged prone positioning (over 48 hours) versus intermittent daily prone positioning (16 to 24 hours) in patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. The study aims to determine if prolonged sessions can improve survival rates and reduce medical complications compared to the standard intermittent approach. It also evaluates the safety of both positioning methods in this critical patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Known pregnancy
* Anticipating withdrawal of life support or shift to palliative care

Where it's running

• Hospital Britanico
  Buenos Aires, Argentina Recruiting
• Sanatorio Güemes
  Buenos Aires, Argentina Recruiting
• Sanatorio Mitre
  Buenos Aires, Argentina Recruiting
• Hospital San Martin de la Plata, Argentina
  La Plata, Argentina Recruiting
• Hospital Vera Barros
  La Rioja, Argentina Recruiting
• Hospital Privado de comunidad
  Mar del Plata, Argentina Recruiting

Study contacts

• Principal investigator: Alejandro Bruhn, MD, PhD — Pontificia Universidad Catolica de Chile
• Study coordinator: Alejandro Bruhn, MD, PhD
• Email: abruhn@uc.cl
• Phone: +56223543292

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Right‑heart function and heart–lung interaction during ARDS with mechanical ventilation

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• Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS

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• Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

  This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.

  Recruiting Phase 1/2 Changchun Tuohua Pharmaceutical Co., Ltd. · Wuhan, Hubei · NCT07413978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.