An observational study in Respiratory Mechanics, Monitoring, Physiologic and Respiratory Insufficiency Requiring Mechanical Ventilation, sponsored by Fundació d'investigació Sanitària de les Illes Balears. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Fundació d'investigació Sanitària de les Illes Balears · Observational
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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 120 is below the median of 140 across 814 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Fundació d'investigació Sanitària de les Illes Balears is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
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Adult patients admitted to Intensive Care Unit who require invasive mechanical ventilation due to any cause with 36 hours or more with a controlled mode of mechanical ventilation and deep sedation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Daily Inspiratory Effort: diaphragmatic thickening fraction.
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 (%).
Time frame: 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.
Daily Inspiratory Effort: pressure muscle index
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
Time frame: 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.
Daily Inspiratory Effort: maximum occlusion pressure
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
Time frame: 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.
Daily Inspiratory Effort: flow index
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
Time frame: 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.
incidence of Ventilator-Associated Pneumonia
proportion of patients who develop ventilator-associated pneumonia based on standard clinical, radiological, and microbiological criteria.
Time frame: 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.
incidence of Intensive Care Unit-Acquired Weakness
development of critical illness weakness evaluated via the Medical Research Council score, which evaluates 6 muscle groups bilaterally, ranging from a total score of 0 (no strength) to 60 (normal muscle strength), where higher scores indicate better muscle strength. Intensive Care Unit-Acquired Weakness will be defined as an MRC sum score of 48 or less.
Time frame: 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.
incidence of delirium
daily screening for delirium using the Confusion Assessment Method for the Intensive Care Unit, which assesses four features: (1) acute onset or fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking. Delirium is defined as positive when features 1 and 2, and either feature 3 or 4 are present.
Time frame: 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.
incidence of mortality
incidence of death by any cause during the study period (handled as a competing risk in the main analysis).
Time frame: 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.
Return to controlled mode of mechanical ventilation
proportion of patients requiring a return to a controlled mechanical ventilation mode due to pressure support ventilation failure before achieving weaning
Time frame: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, death or tracheostomy, assessed up to 28 days.
Plan to share: No — individual participant data will not be share outside the core research team to ensure strict patient confidentiality and comply with local data protection regulations
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Fundació d'investigació Sanitària de les Illes Balears