Dynamic Non-invasive Monitoring of Inspiratory Effort

NCT07839949 | Recruiting

• 1 other identifier: GOIBE226790
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Mechanics; Monitoring, Physiologic; Respiratory Insufficiency Requiring Mechanical Ventilation; Critical Illness

Keywords

Mechanical ventilation weaning, inspiratory effort, monitoring, pressure support ventilation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• incidence of Ventilator-Associated Pneumonia

  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

  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

  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

  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

  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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead

Study Sites (1)

Department of Intensive Care Medicine, Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacinto Espeleta Hernández, MD

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacinto Espeleta Hernández, MD

CONTACT

+34685814532; jacinto.espeleta@ssib.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of critical care medicine

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 24, 2026
• Study Start: August 4, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)