Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorCentre Hospitalier Universitaire de Nice
Academic / other
Locations3 sites (Dijon and 2 other locations)
StatusRecruiting
StartedAugust 8, 2022
Main results expectedAugust 2026
Study endsSeptember 2026
Registry record updatedMay 22, 2026
Trial IDNCT05226247 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.