Clinical Trials in France / NCT05226247
Recruiting
Not applicable
Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)
NCT05226247 · tracked via the Priya Life Science France tracker
Condition(s) studied
Mechanical Ventilation ComplicationPulmonary Edema
Investigational drug(s) / intervention(s)
Spontaneous breathing trial
Spontaneous breathing trial: To perform cardiac and lung echography before and during a spontaneous breathing trial
Study summary
The purpose of this study is to determine if the left and right ventricular systolic function is involved in the development of weaning failure related to weaning-induced pulmonary edema.
Eligibility
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
Primary outcome measure(s)
- Proportion of patients experiencing left and/or right ventricular — 24 months
Left ventricular systolic function will be assessed by several
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Dijon | Dijon | France | Recruiting |
| CHU de NICE | Nice | France | Recruiting |
| Hôpital Cochin | Paris | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05226247 on ClinicalTrials.gov ↗ ← All trials in France