Dynamic, non-invasive monitoring of breathing effort to guide weaning from mechanical ventilation
Official title: Dynamic Analysis of Inspiratory Effort Using Non-invasive Monitoring as a Predictor of Liberation From Invasive Mechanical Ventilation Starting From the Transition Phase to Assisted Spontaneous Ventilation: a Prospective Observational Cohort Study Using Multivariate Joint Modeling and a Bayesian Approach
Run by Fundació d'investigació Sanitària de les Illes Balears · NCT07839949 · Data updated 2026-11-12
This observational study tests whether daily non-invasive measurements of a patient’s breathing effort can predict when it’s safe to take them off invasive ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fundació d'investigació Sanitària de les Illes Balears Government |
| Locations | 1 site (Palma de Mallorca, Balearic Islands) |
| Status | Recruiting |
| Started | August 4, 2026 |
| Main results expected | August 30, 2027 |
| Study ends | August 30, 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07839949 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) on invasive mechanical ventilation for more than 36 hours, transitioned to pressure support ventilation as part of standard care, and able to be followed for 72 hours after weaning.
✕Probably not a fit
Patients who do not show a detectable link between inspiratory effort dynamics and weaning success or who cannot complete 72-hour follow-up may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational cohort will enroll 120 adults who have been on controlled mechanical ventilation for at least 36 hours and are starting pressure support ventilation. Researchers will monitor inspiratory effort daily using four measures—maximum occlusion pressure, muscle pressure index, flow index from waveform analysis, and diaphragmatic thickening fraction via ultrasound—alongside ventilator safety parameters. The goal is to determine how these dynamic breathing effort indicators relate to successful liberation from ventilation, defined by a 72-hour period without invasive support. Data will be collected at the transition to assisted spontaneous breathing and continued for up to 72 hours after liberation when possible. The study aims to improve weaning decisions by identifying early predictors of successful disengagement from ventilation.
Why it matters
Potential benefit: If successful, the approach could help clinicians predict which patients are ready to breathe without invasive support sooner and more safely.
How similar studies have gone: Previous work in mechanical ventilation has explored effort-based predictors, with some promising signals but ongoing need for robust, non-invasive monitoring in diverse ICU populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old or more. * Patients undergoing invasive mechanical ventilation for any cause under a controlled ventilation mode for more than 36 hours. * Attending physician's decision to initiate pressure support ventilation according to standard clinical practice. Exclusion Criteria: * Pregnancy. * Degenerative neuromuscular disease (e.g., amyotrophic lateral sclerosis, congenital myopathies). * Air leak/fistula that prevents breathing-pause maneuvers. * Diaphragmatic paralysis. * Limitation of life-sustaining treatment in case of weaning failure. * Conditions preventing follow-up up to 72 hours after liberation from mechanical ventilation. * Use of neuromuscular blocking agents within the last 24 hours.
Where it's running
-
Department of Intensive Care Medicine, Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain Recruiting
Study contacts
- Principal investigator: Jacinto Espeleta Hernández, MD — Hospital Son Espases
- Study coordinator: Jacinto Espeleta Hernández, MD
- Email: jacinto.espeleta@ssib.es
- Phone: +34685814532
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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.