Comparing prolonged and daily prone positioning for ARDS patients

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

This study is testing if keeping patients with severe lung problems face down for longer periods helps them survive and have fewer complications compared to the usual shorter face-down sessions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 780 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pontificia Universidad Catolica de Chile (other)
• Locations: 6 sites (Concepción and 5 other locations)
• Trial ID: NCT06854627 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are intubated and mechanically ventilated for less than 72 hours with moderate to severe ARDS.

Not a fit: Patients with contraindications for prone positioning or those on extracorporeal membrane oxygenation (ECMO) may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with ARDS undergoing mechanical ventilation.

How similar studies have performed: Previous studies have shown the effectiveness of prone positioning in ARDS, but this specific comparison of prolonged versus intermittent sessions is novel.

Eligibility criteria

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 this trial is running

Concepción and 5 other locations

• Hospital Guillermo Grant Benavente — Concepción, Chile (RECRUITING)
• Complejo Asistencial Dr. Victor Ríos Ruiz — Los Ángeles, Chile (RECRUITING)
• Hospital de Quilpué — Quilpué, Chile (RECRUITING)
• Clínica Las Condes — Santiago, Chile (RECRUITING)
• Hospital Clínico UC Christus — Santiago, Chile (RECRUITING)
• Hospital Clínico Universidad de Chile — Santiago, Chile (RECRUITING)

Study contacts

• Principal investigator: Alejandro Bruhn, MD, PhD — Pontifiia Universidad Catolica de Chile
• Study coordinator: Alejandro Bruhn, MD, PhD

Conditions: Acute Respiratory Distress Syndrome, ACUTE RESPIRATORY DISTRESS SYNDROME, RESPIRATORY FAILURE, PRONE POSITION, MECHANICAL VENTILATION