Dynamic Non-invasive Monitoring of Inspiratory Effort
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
- Respiratory Mechanics
- Monitoring, Physiologic
- Respiratory Insufficiency Requiring Mechanical Ventilation
- Critical Illness
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Enrolment target
- 120
- Started
- 4 August 2026
- Main results due
- 30 August 2027
- Study sites
- 1
- Registry updated
- 24 September 2026
Can you take part?
- No age limit is stated.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
This prospective, observational cohort study aims to evaluate whether the dynamic monitoring of a patient's breathing effort can predict successful liberation from invasive mechanical ventilation. The study will include 120 patients who have undergone 36 hours or more of controlled mechanical ventilation and deep sedation. Patient monitoring will commence immediately upon their transition to an assisted spontaneous breathing mode with pressure support. Starting from this clinical milestone, the researchers will track the patients' longitudinal inspiratory effort daily through four specific variables: maximum occlusion pressure, muscle pressure index, flow index via visual waveform inspection, and diaphragmatic thickening fraction via ultrasound. Concurrently, ventilator safety parameters (plateau pressure, driving pressure, transpulmonary pressure, and compliance) will be recorded. The primary outcome is the time from PSV initiation to successful weaning (defined as 72 hours without ventilator support). Clinical events such as death or return to a controlled mode due to PSV failure will be statistically treated as competing risks. Secondary outcomes include the incidence of pneumonia, ICU-acquired weakness, delirium, mortality, and PSV failure. Data will be analyzed using multivariate joint modeling within a Bayesian framework.
Study sites(1)
Department of Intensive Care Medicine, Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07839949. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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