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NCT Number: NCT07839949

Dynamic Non-invasive Monitoring of Inspiratory Effort

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.

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Key information

Conditions

Respiratory Mechanics Critical Illness Disease Attributes Monitoring, Physiologic Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Insufficiency Requiring Mechanical Ventilation

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Intensive Care Medicine, Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Daily Inspiratory Effort: diaphragmatic thickening fraction.

    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.

    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 (%).

  2. Daily Inspiratory Effort: pressure muscle 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.

    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

  3. Daily Inspiratory Effort: maximum occlusion pressure

    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.

    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

  4. Daily Inspiratory Effort: 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.

    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

Secondary outcomes

  1. incidence of Ventilator-Associated Pneumonia

    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.

    proportion of patients who develop ventilator-associated pneumonia based on standard clinical, radiological, and microbiological criteria.

  2. incidence of Intensive Care Unit-Acquired Weakness

    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.

    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.

  3. incidence of delirium

    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 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.

  4. incidence of mortality

    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 death by any cause during the study period (handled as a competing risk in the main analysis).

  5. Return to controlled mode of mechanical ventilation

    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.

    proportion of patients requiring a return to a controlled mechanical ventilation mode due to pressure support ventilation failure before achieving weaning

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Sponsors and collaborators

Lead sponsor

Fundació d'investigació Sanitària de les Illes Balears

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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