Clinical trial Recruiting at 1 site Observational Ages 18 and up

Inspiratory Effort and Dyspnea During Assisted Mechanical Ventilation in Critically Ill Adults

Official title: Association of Inspiratory Effort With Dyspnea During Assisted Mechanical Ventilation in Critically Ill Patients: A Single-Center Prospective Observational Physiological Study

Run by University of Crete · NCT07877350 · Data updated 2026-11-12

This study tests how different patient breathing efforts relate to breathlessness in adults on assisted mechanical ventilation.

More Mechanical Ventilation trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorUniversity of Crete
Academic / other
Locations1 site (Heraklion)
StatusRecruiting
StartedJune 18, 2026
Main results expectedNovember 30, 2028
Study endsMay 28, 2029
Registry record updatedOctober 16, 2026
Trial IDNCT07877350 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults in the ICU on invasive assisted mechanical ventilation with prolonged or difficult weaning, able to undergo planned physiological monitoring.

Probably not a fit

Patients without measurable changes in inspiratory effort or those not undergoing pressure-support titration may not see direct benefits.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this observational study, researchers explore how a patient’s inspiratory effort interacts with ventilator support during assisted mechanical ventilation. They aim to identify acceptable ranges of effort and how measurements like P0.1, Pes, and PTP relate to dyspnea and weaning outcomes. The study focuses on adults in the ICU who require prolonged or difficult weaning and are on pressure-support or similar assisted modes. Measurement of respiratory effort will be done with esophageal balloon catheters and standard ventilator outputs, while dyspnea assessments capture patient experience. The goal is to improve individualized pressure-support titration to balance prevention of fatigue with avoidance of over-assistance.

Why it matters

Potential benefit: If successful, the findings could help clinicians tailor pressure support to individual patients, potentially reducing dyspnea and facilitating earlier, safer liberation from ventilation.

How similar studies have gone: Previous work has linked inspiratory effort measures with patient-ventilator interaction, but definitive guidance for critically ill patients on assisted ventilation remains limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patient admitted to the ICU.
* Receiving invasive assisted mechanical ventilation in a pressure-support mode or another assisted mode permitting measurement of the prespecified variables.
* Prolonged or difficult weaning.
* Receiving pressure support of at least 5 cmH2O at screening.
* Written informed consent from the participant or legally authorized representative, in accordance with local ethics requirements.
* Ability to undergo the planned physiological monitoring and dyspnea assessment.

Exclusion Criteria:

* Contraindication to nasogastric placement or to placement/use of an esophageal-gastric balloon catheter for Pes and Pgas measurement.
* Refusal of consent by the participant or legally authorized representative.
* Any clinical condition in which the treating physician considers study measurements or pressure-support titration unsafe (unstable hemodynamics, uncontrolled arrhythmia, severe hypoxemia, active myocardial ischemia etc.)

Where it's running

  • University Hospital of Heraklion
    Heraklion, Greece
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.