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

Mechanical Ventilation Complication Clinical Trial

— SystoWean  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226247
• Other study ID #: 21-PP-28
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Mathieu JOZWIAK, MD, PhD
• Phone: 33492035510
• Email: jozwiak.m[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Mechanical Ventilation Complication
• Pulmonary Edema

Intervention

Procedure:
• Spontaneous breathing trial
To perform cardiac and lung echography before and during a spontaneous breathing trial

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon
France	CHU de NICE	Nice
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients experiencing left and/or right ventricular	Left ventricular systolic function will be assessed by several	24 months
Secondary	Proportion of patients experiencing a weaning-induced pulmonary	WiPO is defined by new acute respiratory failure during spontaneous	24 months
Secondary	Clinical and echocardiographic predictors of weaning-induced	To test the ability of different clinical and echocardiographic	24 months