Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study) (SystoWean)
Primary Purpose
Mechanical Ventilation Complication, Pulmonary Edema
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spontaneous breathing trial
Sponsored by
About this trial
This is an interventional diagnostic trial for Mechanical Ventilation Complication
Eligibility Criteria
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
Sites / Locations
- CHU de Dijon
- CHU de NICE
- Hôpital Cochin
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
high-risk of weaning-induced pulmonary edema
Arm Description
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.
Outcomes
Primary Outcome Measures
Proportion of patients experiencing left and/or right ventricular
Left ventricular systolic function will be assessed by several
Secondary Outcome Measures
Proportion of patients experiencing a weaning-induced pulmonary
WiPO is defined by new acute respiratory failure during spontaneous
Clinical and echocardiographic predictors of weaning-induced
To test the ability of different clinical and echocardiographic
Full Information
NCT ID
NCT05226247
First Posted
January 18, 2022
Last Updated
February 1, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT05226247
Brief Title
Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)
Acronym
SystoWean
Official Title
Evaluation of the Role of Systolic Dysfunction in Weaning Failure Related to Weaning-induced Pulmonary Edema: the SystoWean Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Pulmonary Edema
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort Study
Masking
None (Open Label)
Masking Description
All echographic measurements will be analyzed offline, blinded to the patients' response to spontaneous breathing trial
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high-risk of weaning-induced pulmonary edema
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spontaneous breathing trial
Intervention Description
To perform cardiac and lung echography before and during a spontaneous breathing trial
Primary Outcome Measure Information:
Title
Proportion of patients experiencing left and/or right ventricular
Description
Left ventricular systolic function will be assessed by several
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Proportion of patients experiencing a weaning-induced pulmonary
Description
WiPO is defined by new acute respiratory failure during spontaneous
Time Frame
24 months
Title
Clinical and echocardiographic predictors of weaning-induced
Description
To test the ability of different clinical and echocardiographic
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu JOZWIAK, MD, PhD
Phone
33492035510
Email
jozwiak.m@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean DELLAMONICA, MD, PhD
Phone
33492035510
Email
dellamonica.j@chu-nice.fr
Facility Information:
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bélaïd BOUHEMAD, MD, PhD
Phone
33 3 8018 13 09
Email
belaid_bouhemad@hotmail.com
Facility Name
CHU de NICE
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu JOZWIAK, Md, PhD
Phone
+33492035510
Email
jozwiak.m@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Jean DELLAMONICA, MD, PhD
Phone
+33492035510
Email
dellamonica.j@chu-nice.fr
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Driss LAGHLAM
Phone
33158412517
Email
driss.laghlam@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan is established
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Systolic Function and Weaning-induced Pulmonary Edema (SystoWean Study)
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