Mechanical Ventilation ComplicationSystoWeanNCT05226247
Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)
A study testing Spontaneous breathing trial in people with Mechanical Ventilation Complication and Pulmonary Edema, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Pulmonary Edema
- What is being tested?
- Spontaneous breathing trial
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Aug 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Obesity, defined by a body mass index> 30 kg/m²
- Chronic obstructive pulmonary disease
- Chronic heart disease
Who cannot join
- Age <18 years and pregnant women
- Patients with a decision of not to resuscitate
- Poor echogenicity
- Severe mitral valve disease (leakage and/or stenosis, bioprosthesis)
- Patients with pacemaker
- Tracheostomy
- Chronic neuromuscular or neurodegenerative diseases
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Dijon
Dijon, 21079
Bélaïd BOUHEMAD, MD, PhD, 33 3 8018 13 09, belaid_bouhemad@hotmail.com
- Recruiting
CHU de NICE
Nice, 06200
Mathieu JOZWIAK, Md, PhD, +33492035510, jozwiak.m@chu-nice.fr
Jean DELLAMONICA, MD, PhD, +33492035510, dellamonica.j@chu-nice.fr
- Recruiting
Hôpital Cochin
Paris, 75014
Driss LAGHLAM, 33158412517, driss.laghlam@gmail.com
About this study
Official title: Evaluation of the Role of Systolic Dysfunction in Weaning Failure Related to Weaning-induced Pulmonary Edema: the SystoWean Study
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.
Read the detailed description
Weaning from mechanical ventilation remains a central step in the management of critically-ill patients, since weaning failure and prolonged duration of mechanical ventilation are not only associated with an increase in the length of stay in intensive care but also with greater morbidity and mortality. One of the well-recognized causes of weaning failure is weaning-induced pulmonary edema (WIPO), which accounts for almost 60% of the causes of weaning failure and ranging up to 75% in high-risk patients, i.e. patients with medical history of chronic heart disease, chronic respiratory failure and obesity.
Echocardiography is increasingly used in intensive care and allows non-invasive assessment of diastolic function as well as left ventricular (LV) and right (RV) systolic function, including during a spontaneous breathing test. Although LV diastolic dysfunction appears to be a major determinant of WIPO, the role of LV and RV systolic dysfunction is less unequivocal and has been poorly studied so far. Scarce data showed that patients experiencing WIPO tended to exhibit more frequently LV systolic dysfunction, as demonstrated by a lower LV ejection fraction (LVEF) and no study but two have investigated the potential role of RV systolic function. Moreover, assessing LV systolic function with LVEF measurement suffers from several limitations, especially in critically-ill patients.
Thus, the main goal of this study is to investigate whether LV and RV systolic function is involved in the development of WIPO. The second goal of this study is to determine the best echocardiographic parameter to assess LV and RV systolic function during the weaning process.
- Being tested
- Spontaneous breathing trial
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous breathing trialProcedure or surgery
To perform cardiac and lung echography before and during a spontaneous breathing trial
| Study group | Role | What they receive |
|---|---|---|
| high-risk of weaning-induced pulmonary edema | Other | Critically-ill patients under mechanical ventilation for more than 48h, who are at high-risk of weaning-induced pulmonary edema and in whom the attending physician decided to perform a spontaneous breathing trial. Receives: Procedure: Spontaneous breathing trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing left and/or right ventricular
Left ventricular systolic function will be assessed by several
Measured: 24 months
Secondary outcomes (2)
Proportion of patients experiencing a weaning-induced pulmonary
WiPO is defined by new acute respiratory failure during spontaneous
Measured: 24 months
Clinical and echocardiographic predictors of weaning-induced
To test the ability of different clinical and echocardiographic
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start8 Aug 2022
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort Study
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226247
- Sponsor's protocol ID
- 21-PP-28
- Acronym
- SystoWean
- Status last verified
- May 2026
- First submitted
- 18 Jan 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan is established
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Systolic Dysfunction in Weaning Failure Related to Weaning-induced Pulmonary Edema: the SystoWean Study
- ClinicalTrials.gov ID
- NCT05226247
- Acronym / sponsor ID
- SystoWean / 21-PP-28
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Weaning from mechanical ventilation remains a central step in the management of critically-ill patients, since weaning failure and prolonged duration of mechanical ventilation are not only associated with an increase in the length of stay in intensive care but also with greater morbidity and mortality. One of the well-recognized causes of weaning failure is weaning-induced pulmonary edema (WIPO), which accounts for almost 60% of the causes of weaning failure and ranging up to 75% in high-risk patients, i.e. patients with medical history of chronic heart disease, chronic respiratory failure and obesity.
Echocardiography is increasingly used in intensive care and allows non-invasive assessment of diastolic function as well as left ventricular (LV) and right (RV) systolic function, including during a spontaneous breathing test. Although LV diastolic dysfunction appears to be a major determinant of WIPO, the role of LV and RV systolic dysfunction is less unequivocal and has been poorly studied so far. Scarce data showed that patients experiencing WIPO tended to exhibit more frequently LV systolic dysfunction, as demonstrated by a lower LV ejection fraction (LVEF) and no study but two have investigated the potential role of RV systolic function. Moreover, assessing LV systolic function with LVEF measurement suffers from several limitations, especially in critically-ill patients.
Thus, the main goal of this study is to investigate whether LV and RV systolic function is involved in the development of WIPO. The second goal of this study is to determine the best echocardiographic parameter to assess LV and RV systolic function during the weaning process.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort Study
| Arm | Type | Receives |
|---|---|---|
| high-risk of weaning-induced pulmonary edema | Other | Procedure: Spontaneous breathing trialCritically-ill patients under mechanical ventilation for more than 48h, who are at high-risk of weaning-induced pulmonary edema and in whom the attending physician decided to perform a spontaneous breathing trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Patients at high risk of weaning-induced pulmonary edema (WIPO), defined by one or more of the following criteria:
Key exclusion criteria (7 listed)
- Age <18 years and pregnant women
- Patients with a decision of not to resuscitate
- Poor echogenicity
- Severe mitral valve disease (leakage and/or stenosis, bioprosthesis)
- Patients with pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spontaneous breathing trialTo perform cardiac and lung echography before and during a spontaneous breathing trial | Procedure or surgery | high-risk of weaning-induced pulmonary edema |
Primary outcome
Proportion of patients experiencing left and/or right ventricular
Time frame: 24 months
Left ventricular systolic function will be assessed by several
2 secondary outcomes
Proportion of patients experiencing a weaning-induced pulmonary
Time frame: 24 months
Clinical and echocardiographic predictors of weaning-induced
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. No plan is established
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spontaneous breathing trial in people with Mechanical Ventilation Complication and Pulmonary Edema, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu JOZWIAK, MD, PhD (33492035510, jozwiak.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients experiencing left and/or right ventricular (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.