Investigating heart function's role in weaning from mechanical ventilation
Official title: Evaluation of the Role of Systolic Dysfunction in Weaning Failure Related to Weaning-induced Pulmonary Edema: the SystoWean Study
Run by Centre Hospitalier Universitaire de Nice · NCT05226247 · Data updated 2026-11-12
This study is testing how heart function affects the ability of critically ill patients on mechanical ventilation to breathe on their own without developing lung problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 3 sites (Dijon and 2 other locations) |
| Status | Recruiting |
| Started | August 8, 2022 |
| Main results expected | August 2026 |
| Study ends | September 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT05226247 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients who have been on mechanical ventilation for more than 48 hours and are at high risk for weaning-induced pulmonary edema due to conditions like obesity or chronic heart disease.
✕Probably not a fit
Patients under 18 years old, those with a decision of not to resuscitate, or those with severe heart valve disease 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 study aims to explore the relationship between left and right ventricular systolic function and the occurrence of weaning-induced pulmonary edema (WIPO) in critically ill patients undergoing mechanical ventilation. It focuses on patients who have been on invasive mechanical ventilation for over 48 hours and are deemed suitable for a spontaneous breathing trial. By utilizing echocardiography, the study will assess the systolic function of the heart to determine its impact on weaning success and the risk of pulmonary edema. The findings could provide insights into improving weaning strategies and patient outcomes in intensive care settings.
Why it matters
Potential benefit: If successful, this study could lead to improved weaning protocols and reduced complications for critically ill patients on mechanical ventilation.
How similar studies have gone: While some studies have explored aspects of heart function in relation to weaning, this specific investigation into the role of both left and right ventricular systolic function in WIPO is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Invasive mechanical ventilation for more than 48 hours 2. Patients indicated, according to intensivists, for carrying out a spontaneous breathing trial weaning test, based on the presence of all of the following criteria: 1. SpO2\> 90% with FiO2 ≤40% and PEEP ≤5 cmH2O 2. Cough effectiveness on tracheal aspirations 3. Lack of hemodynamic instability and of disorders of consciousness 3. Patients at high risk of weaning-induced pulmonary edema (WIPO), defined by one or more of the following criteria: 1. Obesity, defined by a body mass index\> 30 kg/m² 2. Chronic obstructive pulmonary disease 3. Chronic heart disease Exclusion Criteria: 1. Age \<18 years and pregnant women 2. Patients with a decision of not to resuscitate 3. Poor echogenicity 4. Severe mitral valve disease (leakage and/or stenosis, bioprosthesis) 5. Patients with pacemaker 6. Tracheostomy 7. Chronic neuromuscular or neurodegenerative diseases
Where it's running
-
CHU de Dijon
Dijon, France Recruiting -
CHU de NICE
Nice, France Recruiting -
Hôpital Cochin
Paris, France Recruiting
Study contacts
- Study coordinator: Mathieu JOZWIAK, MD, PhD
- Email: jozwiak.m@chu-nice.fr
- Phone: 33492035510
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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.