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

NCT05226247 | Recruiting

• 1 other identifier: 21-PP-28
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Mechanical Ventilation Complication; Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing left and/or right ventricular

  Left ventricular systolic function will be assessed by several

  24 months

Secondary Outcomes (2)

• Proportion of patients experiencing a weaning-induced pulmonary

  24 months

• Clinical and echocardiographic predictors of weaning-induced

  24 months

Study Arms (1)

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.

Procedure: Spontaneous breathing trial

Interventions

Spontaneous breathing trial PROCEDURE

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

high-risk of weaning-induced pulmonary edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

CHU de Dijon

Dijon, 21079, France

RECRUITING

CHU de NICE

Nice, 06200, France

RECRUITING

Hôpital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mathieu JOZWIAK, MD, PhD

CONTACT

33492035510; jozwiak.m@chu-nice.fr

Jean DELLAMONICA, MD, PhD

CONTACT

33492035510; dellamonica.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All echographic measurements will be analyzed offline, blinded to the patients' response to spontaneous breathing trial
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort Study

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 7, 2022
• Study Start: August 8, 2022
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)