Evaluating Heart Function During Breathing Trials in ICU Patients
Official title: Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
Run by Centre Hospitalier Régional d'Orléans · NCT06923267 · Data updated 2026-11-12
This study tests which type of breathing trial is easiest on the heart for ICU patients who are trying to breathe on their own without help from machines.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | April 9, 2027 |
| Study ends | May 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06923267 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are intubated adults in the ICU who have been on mechanical ventilation for at least 24 hours and are at high risk for re-intubation due to underlying cardiac or respiratory conditions.
✕Probably not a fit
Patients with neuromuscular pathology, pregnant or breastfeeding women, or those under legal protection may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess cardiac function in ICU patients undergoing spontaneous breathing trials by measuring a specific cardiac ultrasound index (E/E'). The study will compare three different spontaneous breathing trials to determine which one places the least strain on the heart. Participants will simply breathe without respiratory support during these trials, while investigators will conduct cardiac ultrasound measurements to gather data. The goal is to identify the most effective method for weaning patients off mechanical ventilation.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of weaning patients from mechanical ventilation.
How similar studies have gone: Other studies have explored cardiac function during weaning from mechanical ventilation, suggesting that this approach has potential but may still be novel in its specific methodology.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intubated patient undergoing invasive mechanical ventilation for at least 24 hours and scheduled for a spontaneous breathing trial * Richmond Agitation Sedation Scale (RASS) between -1 and +1 * Patient at high risk of re-intubation with at least one of the following criteria: * Underlying cardiac disease (left ventricular dysfunction with left ventricular ejection fraction ≤ 45%, documented ischemic heart disease, chronic atrial fibrillation, known history of cardiogenic pulmonary edema) * Underlying respiratory disease (COPD, Emphysema, bronchial dilatation, asthma, obesity/hypoventilation syndrome, restrictive lung disease) Exclusion Criteria: * Neuromuscular pathology (myasthenia type) preceding hospitalization * Pregnant or breast-feeding women * Patient already included in the study * Protected person (under guardianship or curatorship) * Person under court protection * Person not affiliated to a social security scheme
Where it's running
-
Chu Orleans
Orléans, France Recruiting
Study contacts
- Study coordinator: Guillaume Fossat, Pt, Msc, PhD student
- Email: guillaume.fossat@chu-orleans.fr
- Phone: +33238651318
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study will test whether combining heart rate variability from a wearable ECG sensor with standard weaning tests can help doctors decide when patients on mechanical ventilation are ready to have the breathing tube removed.
-
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-
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Monitoring diaphragm electrical activity and breathing effort during ventilator weaning
We will see if surface diaphragm EMG, esophageal pressure, and oxygen use measured during a spontaneous breathing trial can predict who will fail to wean from the ventilator in the ICU.
-
Readiness for EXtubation (REXs) score for patients on invasive mechanical ventilation
This will test the Readiness for EXtubation (REXs) score to see if it can predict which ICU patients on invasive mechanical ventilation can be safely extubated.
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ICU rehabilitation for adults on invasive mechanical ventilation
This project will look at rehabilitation approaches used in ICUs worldwide to see if they relate to outcomes for adults who have been on invasive mechanical ventilation for at least 48 hours.
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.