PEEP levels and breathing effort during assisted mechanical ventilation
Official title: Impact of Positive End-Expiratory Pressure on the Modulation of Respiratory Effort During Assisted Ventilation: A Physiological Randomized Crossover Study
Run by Pontificia Universidad Catolica de Chile · NCT07437846 · Data updated 2026-11-12
This trial tests whether changing PEEP levels can reduce excessive breathing effort in adults receiving assisted mechanical ventilation in the ICU.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Santiago Metropolitan) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | April 2026 |
| Study ends | July 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07437846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) in the ICU receiving invasive assisted mechanical ventilation with spontaneous effort, clinically stable for PEEP adjustments, and able to provide informed consent or have a legal representative do so.
✕Probably not a fit
Patients who are apneic, deeply sedated or paralyzed, hemodynamically unstable, pregnant, have contraindications to esophageal balloon placement, or have neurological conditions that blunt respiratory drive are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized crossover physiological trial that applies four predefined PEEP levels to adults on assisted invasive mechanical ventilation and compares breathing effort and respiratory mechanics across those settings. Participants are clinically stable ICU patients with spontaneous breathing who can tolerate protocolized PEEP changes. Measurements likely include inspiratory effort (for example via esophageal pressure), ventilator waveforms, and lung mechanics at each PEEP level. The goal is to characterize how PEEP directly influences inspiratory drive and potential risk of lung or diaphragmatic injury during assisted ventilation.
Why it matters
Potential benefit: If successful, the trial could identify PEEP settings that reduce harmful inspiratory effort and help lower the risk of patient self-inflicted lung or diaphragmatic injury during assisted ventilation.
How similar studies have gone: Previous physiologic studies show PEEP can change lung mechanics and inspiratory effort, but its direct effects during assisted spontaneous breathing are not well established and findings have been mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age ≥18 years. * ICU patients receiving invasive mechanical ventilation (endotracheal tube or tracheostomy). * Ventilated in an assisted mode with spontaneous breathing * Clinically stable to undergo protocolized PEEP changes. * Sedation level compatible with spontaneous breathing and ventilator triggering * Informed consent from the patient or legally authorized representative. Exclusion Criteria: * Contraindication to esophageal balloon placement (if applicable). * Significant hemodynamic instability or unstable vasopressor requirements. * Unstable arrhythmia or active myocardial ischemia. * Undrained pneumothorax or major air leak. * Controlled ventilation without effective spontaneous effort (apnea, neuromuscular blockade, deep sedation). * Pregnancy * Acute or chronic neurological conditions that may impair respiratory drive or interfere with the regulation of spontaneous breathing.
Where it's running
-
Hospital Clinico UC
Santiago, Santiago Metropolitan, Chile Recruiting
Study contacts
- Principal investigator: Roque Basoalto, PhD, Msc, Physioterapy — Pontifica Universidad Catolica de Chile
- Study coordinator: Diego Lopez Arnello, Physioterapy
- Email: diegon.lopez@uc.cl
- Phone: +56973805897
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.