Respiratory MechanicsNCT07839949
Dynamic Non-invasive Monitoring of Inspiratory Effort
An observational study of Respiratory Mechanics and Monitoring, Physiologic, run by Fundació d'investigació Sanitària de les Illes Balears at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Mechanics, Monitoring, Physiologic, Respiratory Insufficiency Requiring Mechanical Ventilation
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 4 Aug 2026to 30 Aug 2027
- How long will I take part?
- 28 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Department of Intensive Care Medicine, Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Jacinto Espeleta Hernández, MD, +34685814532, jacinto.espeleta@ssib.es
About this study
Official 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
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
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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
proportion of patients who develop ventilator-associated pneumonia based on standard clinical, radiological, and microbiological criteria.
Measured: 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: 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: 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: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start4 Aug 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MechanicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacinto Espeleta Hernández, Fundació d'investigació Sanitària de les Illes Balears
- Investigators
- Jacinto Espeleta Hernández, MD, Principal investigator, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839949
- Sponsor's protocol ID
- GOIBE226790
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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