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Recruiting NCT05226247

NCT05226247 Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)

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Clinical Trial Summary
NCT ID NCT05226247
Status Recruiting
Phase
Sponsor Centre Hospitalier Universitaire de Nice
Condition Mechanical Ventilation Complication
Study Type INTERVENTIONAL
Enrollment 250 participants
Start Date 2022-08-08
Primary Completion 2026-08

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Spontaneous breathing trial

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 250 participants in total. It began in 2022-08-08 with a primary completion date of 2026-08.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Mathieu JOZWIAK, MD, PhD

✉ jozwiak.m@chu-nice.fr

📞 33492035510

Frequently Asked Questions

Who can join the NCT05226247 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Mechanical Ventilation Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05226247 currently recruiting?

Yes, NCT05226247 is actively recruiting participants. Contact the research team at jozwiak.m@chu-nice.fr for enrollment information.

Where is the NCT05226247 trial being conducted?

This trial is being conducted at Dijon, France, Nice, France, Paris, France.

Who is sponsoring the NCT05226247 clinical trial?

NCT05226247 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 250 participants.

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