Evaluating Heart Function During Breathing Trials in ICU Patients
Ultrasound Evaluation of Cardiac Function During Three Spontaneous Breathing Trials in Intensive Care Unit : A Prospective Interventional Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT06923267 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with neuromuscular pathology, pregnant or breastfeeding women, or those under legal protection may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orléans
- Chu Orleans — Orléans, France (Recruiting)
Study contacts
- Study coordinator: Guillaume Fossat, Pt, Msc, PhD student
- Email: guillaume.fossat@chu-orleans.fr
- Phone: +33238651318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.