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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Daily Inspiratory Effort: diaphragmatic thickening fraction. — Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days. Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using diaphragmatic thickening fraction measured via ultrasound.
Unit of measure: percentage (%).
Daily Inspiratory Effort: pressure muscle index — Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days. Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using the pressure muscle index measured in the mechanical ventilator during an end-inspiratory occlusion maneuver.
Unit of measure: centimeters of water
Daily Inspiratory Effort: maximum occlusion pressure — Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days. Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using the maximum occlusion pressure measured in the mechanical ventilator during an end-espiratory occlusion maneuver.
Unit of measure: centimeters of water
Daily Inspiratory Effort: flow index — Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days. Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using a qualitative evaluation by analyzing the airway flow waveform on the mechanical ventilator. The profile is categorized daily as positive (presence of effort) or negative (absence of effort). For reporting and analytical purposes, this qualitative assessment is coded as a binary scale where 0 indicates a negative flow index and 1 indicates a positive flow index. Individual daily data trajectories will be analyzed using a Bayesian joint model.
Unit of measure: score on a scale, where 0 represents negative flow index and 1 represents a positive flow index
Trial sites (1)
Facility
City
Region
Status
Department of Intensive Care Medicine, Hospital Universitario Son Espases
Palma de Mallorca
Balearic Islands
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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