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NCT Number: NCT05226247

Systolic Function and Weaning-induced Pulmonary Edema (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Dijon, Dijon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Chronic heart disease

Exclusion criteria

  • 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

Treatment and study plan

Spontaneous breathing trial

Procedure

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

Primary outcomes

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

    Time frame: 24 months

    Left ventricular systolic function will be assessed by several

Secondary outcomes

  1. Proportion of patients experiencing a weaning-induced pulmonary

    Time frame: 24 months

    WiPO is defined by new acute respiratory failure during spontaneous

  2. Clinical and echocardiographic predictors of weaning-induced

    Time frame: 24 months

    To test the ability of different clinical and echocardiographic

Study contacts

Contact information is provided by the study sponsor or research team.

Jean DELLAMONICA, MD, PhD

CONTACT

[email protected]

33492035510

Mathieu JOZWIAK, MD, PhD

CONTACT

[email protected]

33492035510

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: SystoWean

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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