Exploring the effects of positioning and binding on lung and muscle health in ARDS patients
Effect of Prone Positioning and Abdominal Binding on Lung and Muscle Protection in ARDS Patients With ICU-acquired Weakness Transitioning From Controlled to Spontaneous Breathing
NA · University of Chile · NCT05826847
This study is testing different ways to help patients with ARDS breathe better and keep their muscles healthy as they move from using a ventilator to breathing on their own.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chile (other) |
| Locations | 1 site (Independencia) |
| Trial ID | NCT05826847 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different ventilatory strategies, including prone positioning and thoracoabdominal binding, on lung and muscle function in patients with acute respiratory distress syndrome (ARDS) who are transitioning from controlled to spontaneous breathing. It consists of three steps: a multimodal assessment of muscle and lung function, a crossover trial comparing various ventilatory approaches, and a randomized controlled trial evaluating the effects on lung inflammation and injury biomarkers. The goal is to identify methods that can reduce complications associated with prolonged mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates are adult patients with moderate to severe ARDS who have been on controlled mechanical ventilation for more than three days and are hemodynamically stable.
Not a fit: Patients with unstable hemodynamics, tracheostomy, or significant central nervous system injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved lung and muscle protection strategies for ARDS patients, potentially reducing hospital mortality and chronic disability.
How similar studies have performed: While the approach of using positioning and binding in ARDS patients is being explored, this specific combination of interventions is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult ARDS patients with moderate-severe ARDS on controlled protective mechanical ventilation for more than 3 days * Stable hemodynamics * Level of consciousness enough to initiate spontaneous breathing Exclusion Criteria: * Unstable hemodynamics * Tracheostomy * Abnormal level of consciousness * Central nervous system injury * Esophageal varices * Pregnancy * Contraindications for installation of electrical impedance tomography or ultrasound assessments
Where this trial is running
Independencia
- Hospital Clínico Universidad de Chile — Independencia, Chile (RECRUITING)
Study contacts
- Principal investigator: Rodrigo Cornejo — University of Chile
- Study coordinator: Rodrigo Cornejo
- Email: racornej@gmail.com
- Phone: +56229788264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication, ICU Acquired Weakness