Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study) (NCT05226247) | Clinical Trial Compass
RecruitingNot Applicable
Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)
France250 participantsStarted 2022-08-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Invasive mechanical ventilation for more than 48 hours
. Patients indicated, according to intensivists, for carrying out a spontaneous breathing trial weaning test, based on the presence of all of the following criteria:
. SpO2\> 90% with FiO2 ≤40% and PEEP ≤5 cmH2O
. Cough effectiveness on tracheal aspirations
. Lack of hemodynamic instability and of disorders of consciousness
. Patients at high risk of weaning-induced pulmonary edema (WIPO), defined by one or more of the following criteria:
. Obesity, defined by a body mass index\> 30 kg/m²
. Chronic obstructive pulmonary disease
Exclusion criteria
. Age \<18 years and pregnant women
. Patients with a decision of not to resuscitate
. Poor echogenicity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients experiencing left and/or right ventricular