Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling (EVALDM)

September 21, 2021 updated by: Centre Hospitalier Metropole Savoie

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bourg-en-Bresse, France
        • Recruiting
        • CH Bourg en Bresse
        • Contact:
          • Nicholas Sedillot
        • Sub-Investigator:
          • Camille Bouisse
        • Sub-Investigator:
          • Jean-Baptiste Palluy
        • Sub-Investigator:
          • Yves Poncelin de Raucourt
        • Sub-Investigator:
          • Adrien Robine
        • Sub-Investigator:
          • Xavier Tchenio
      • Chambéry, France, 73000
        • Recruiting
        • Centre Hospitalier Métropole Savoie
        • Sub-Investigator:
          • Jean-Marc Thouret
        • Principal Investigator:
          • Vincent Peigne
        • Contact:
        • Sub-Investigator:
          • Bénédicte Zerr
        • Sub-Investigator:
          • Vincent Susset
        • Sub-Investigator:
          • Michel Badet
        • Sub-Investigator:
          • Yvonnick Boue
        • Sub-Investigator:
          • David Bouard
        • Sub-Investigator:
          • Catherine Chastagner
        • Sub-Investigator:
          • Julien Lavolaine
        • Sub-Investigator:
          • Mattéo Miquet
        • Sub-Investigator:
          • David Sauvajon
        • Sub-Investigator:
          • Agnès Vinay
        • Sub-Investigator:
          • Stéphane Combaz
        • Sub-Investigator:
          • Clémence Fauche
      • La Tronche, France, 38700
        • Recruiting
        • Chu Grenoble Alpes
        • Principal Investigator:
          • Nicolas Terzi
        • Contact:
          • Terzi Nicolas
        • Sub-Investigator:
          • Carole SCHWEBEL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mitral doppler
Mitral doppler before and after vascular filling
Diagnostic test: mitral doppler
Mitral doppler before and after vascular filling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of the occuring of premature degradation respiratory
Time Frame: 30 minutes after vascular filling
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Metropole Savoie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CHMS17002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiration, Artificial

Clinical Trials on mitral doppler

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe