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NCT03447366 Clinical Trial

Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling

Respiration, Artificial Clinical Trial

— EVALDM  

Official title:
Assessment of Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling for ICU Patients With Mechanical Ventilation. The EVALDM Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03447366
Other study ID # CHMS17002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2018
Est. completion date February 2023

Study information
Verified date September 2021
Source Centre Hospitalier Metropole Savoie
Contact Vincent Peigne
Phone 0479966152
Email vincent.peigne@ch-metropole-savoie.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.

Description:

Mitral Doppler will be performed before vascular filling. Patients will be classified in two groups (normal or high cardiac filling pressure). The evolution of the respiratory data (SpO2/FiO2) of the two groups of the patients before and after vascular filling will be compared.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date February 2023
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Mechanical ventilation - And hemodynamic failure - And decision of the attending physician to perform a vascular filling Exclusion Criteria: - Pregnancy and breast-feeding women - Patients deprived of their administrative or judicial freedom

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• mitral doppler
Mitral doppler before and after vascular filling

Locations
Country Name City State
France Ch Bourg En Bresse Bourg-en-Bresse
France Centre Hospitalier Metropole Savoie Chambéry
France CHU Grenoble Alpes La Tronche

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of the occuring of premature degradation respiratory definied by a reduction of at least 15% of the SpO2/FiO2 ratio in the 30min following the vascular filling 30 minutes after vascular filling
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