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

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 Overview

• Status: Recruiting
• Conditions: Critical Illness; Monitoring, Physiologic; Respiratory Mechanics; Respiratory Insufficiency Requiring Mechanical Ventilation

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Jacinto Espeleta Hernández, MD; Phone Number: +34685814532; Email: jacinto.espeleta@ssib.es

Study Locations

• Spain
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 07120
      • Recruiting
      • Department of Intensive Care Medicine, Hospital Universitario Son Espases
      • Contact: Jacinto Espeleta Hernández, MD; Phone Number: +34685814532; Email: jacinto.espeleta@ssib.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	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	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	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Ventilator-Associated Pneumonia	proportion of patients who develop ventilator-associated pneumonia based on standard clinical, radiological, and microbiological criteria.	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.	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.	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).	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	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.

Collaborators and Investigators

• Sponsor: Fundació d'investigació Sanitària de les Illes Balears
• Investigators: Principal Investigator: Jacinto Espeleta Hernández, MD, Hospital Son Espases

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: September 15, 2026
• First Submitted That Met QC Criteria: September 20, 2026
• First Posted (Actual): September 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 20, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical ventilation weaning, inspiratory effort, monitoring, pressure support ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: GOIBE226790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

individual participant data will not be share outside the core research team to ensure strict patient confidentiality and comply with local data protection regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No