Investigating heart function's role in weaning from mechanical ventilation

Evaluation of the Role of Systolic Dysfunction in Weaning Failure Related to Weaning-induced Pulmonary Edema: the SystoWean Study

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 3 sites (Dijon and 2 other locations)
• Trial ID: NCT05226247 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Dijon and 2 other locations

• 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

Conditions Mechanical Ventilation Complication; Pulmonary Edema