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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Crete Academic / other |
| Locations | 1 site (Heraklion) |
| Status | Recruiting |
| Started | June 18, 2026 |
| Main results expected | November 30, 2028 |
| Study ends | May 28, 2029 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07877350 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
- Study coordinator: Katerina Vaporidi, MD, PhD
- Email: vaporidi@uoc.gr
- Phone: +30 2810 392718 / 2810 394729
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Measuring breathing drive and effort at different pressure support levels after major abdominal surgery
This project will test whether changing pressure support levels can reveal under- or over-assistance of breathing in adults on ventilators after major abdominal surgery.
-
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This study tests whether pulse wave EIT or saline bolus EIT can best show lung blood flow in ARDS patients on mechanical ventilation.
-
Computed inspiratory muscle pressure to monitor inspiratory effort during pressure-targeted assist/control ventilation
This study tests a noninvasive computed pressure method (cPmus) to see if it matches the traditional esophageal pressure method for measuring inspiratory effort in adults on pressure-targeted ventilation with spontaneous breathing.
-
Noninvasive estimate of inspiratory effort to monitor pressure support ventilation
This study tests whether a noninvasive computed inspiratory muscle pressure (cPmus) can match the traditional esophageal pressure method for adults on pressure support ventilation.
-
Driving pressure-guided individualized PEEP vs standard PEEP during upper abdominal surgery
In this randomized trial, adults at higher risk of breathing problems after upper abdominal surgery will try a personalized PEEP level based on the lowest driving pressure and compare it to a fixed PEEP of 5 cmH2O to see if it lowers postoperative lung complications.
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FCV vs VC—Obese Adults Undergoing Laparoscopic Surgery
In obese adults having laparoscopic surgery, researchers will see if flow-controlled ventilation (FCV) works better than volume-controlled ventilation with autoflow (VC-AF) at keeping airway pressures and lung energy lower.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.