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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication; Pulmonary Edema
• Intervention / Treatment: Procedure: Spontaneous breathing trial

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieu JOZWIAK, MD, PhD; Phone Number: 33492035510; Email: jozwiak.m@chu-nice.fr
• Study Contact Backup: Name: Jean DELLAMONICA, MD, PhD; Phone Number: 33492035510; Email: dellamonica.j@chu-nice.fr

Study Locations

• France
  • Dijon, France, 21079
    • Recruiting
    • CHU de Dijon
    • Contact: Bélaïd BOUHEMAD, MD, PhD; Phone Number: 33 3 8018 13 09; Email: belaid_bouhemad@hotmail.com
  • Nice, France, 06200
    • Recruiting
    • Chu de Nice
    • Contact: Jean DELLAMONICA, MD, PhD; Phone Number: +33492035510; Email: dellamonica.j@chu-nice.fr
    • Contact: Mathieu JOZWIAK, Md, PhD; Phone Number: +33492035510; Email: jozwiak.m@chu-nice.fr
  • Paris, France, 75014
    • Recruiting
    • Hôpital Cochin
    • Contact: Driss LAGHLAM; Phone Number: 33158412517; Email: driss.laghlam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; To perform cardiac and lung echography before and during a spontaneous breathing trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients experiencing left and/or right ventricular	Left ventricular systolic function will be assessed by several	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients experiencing a weaning-induced pulmonary	WiPO is defined by new acute respiratory failure during spontaneous	24 months
Clinical and echocardiographic predictors of weaning-induced	To test the ability of different clinical and echocardiographic	24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: 21-PP-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan is established

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No