ClinicalTrials.gg
RecruitingNCT05226247SystoWeanUpdated May 22, 2026

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

An interventional study of Spontaneous breathing trial in Mechanical Ventilation Complication and Pulmonary Edema, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Pulmonary Edema with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Pulmonary Edema · France.

Planned enrollment
2nd of 12
250 · median 79
Started
2022
with 3 others
No phase
10 of 22
4 open now
Registered
13th of 22
by date
Lead sponsor
1 of 22
Centre Hospitalier Universitaire de Nice

Among the 22 studies in Pulmonary Edema with a site in France, this one is the 2nd largest by planned enrollment of the 12 interventional ones, is one of 4 that started in 2022, is one of 10 with no phase, and was the 13th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

No phasethis study10 · 4 open
Observational8 · 2 open
Phase 33 · 0 open
Phase 41 · 0 open

By the year they started

First in 2002; this study’s year is marked. 4 started in 2022.

What they test

Size and results

Median enrollment 79 across the 12 interventional studies, 100 across the 8 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Pulmonary Edema with a site in France, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Mechanical Ventilation Complication
  • Pulmonary Edema

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 > 30 kg/m²
    2. Chronic heart disease

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Other
    high-risk of weaning-induced pulmonary edema

    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.

    Procedure: Spontaneous breathing trial

Interventions

  • ProcedureSpontaneous breathing trial

    To perform cardiac and lung echography before and during a spontaneous breathing trial

06

What researchers measure

Primary outcomes

  1. Proportion of patients experiencing left and/or right ventricular

    Left ventricular systolic function will be assessed by several

    Time frame: 24 months

Secondary outcomes

  1. Proportion of patients experiencing a weaning-induced pulmonary

    WiPO is defined by new acute respiratory failure during spontaneous

    Time frame: 24 months

  2. Clinical and echocardiographic predictors of weaning-induced

    To test the ability of different clinical and echocardiographic

    Time frame: 24 months

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No plan is established

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2022 (actual). Primary completion is estimated for Aug 2026, 48 months after the start.

Of 22 interventional studies with no phase under Pulmonary Edema, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 69. This study's planned 48 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2022
First posted
Feb 7, 2022
StartActual
Aug 8, 2022
Primary completionEst.
Aug 2026
CompletionEst.
Sep 2026
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05226247
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Aug 8, 2022
Primary completion
Aug 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
May 22, 2026

Study contacts

Mathieu JOZWIAK, MD, PhD
Contact
jozwiak.m@chu-nice.fr
33492035510
Jean DELLAMONICA, MD, PhD
Contact
dellamonica.j@chu-nice.fr
33492035510

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion