NCT03447366

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

4.9 years

First QC Date

February 2, 2018

Last Update Submit

September 21, 2021

Conditions

Respiration, ArtificialVascular FillingEchocardiography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Mitral doppler

EXPERIMENTAL

Mitral doppler before and after vascular filling

Diagnostic Test: mitral doppler

Interventions

mitral dopplerDIAGNOSTIC_TEST

Mitral doppler before and after vascular filling

Mitral doppler

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanical ventilation
  • And hemodynamic failure
  • And decision of the attending physician to perform a vascular filling

You may not qualify if:

  • Pregnancy and breast-feeding women
  • Patients deprived of their administrative or judicial freedom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ch Bourg En Bresse

Bourg-en-Bresse, France

RECRUITING

Centre Hospitalier Metropole Savoie

Chambéry, 73000, France

RECRUITING

CHU Grenoble Alpes

La Tronche, 38700, France

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Vincent Peigne

CONTACT

0479966152vincent.peigne@ch-metropole-savoie.fr

Bénédicte Zerr

CONTACT

0479966152benedicte.zerr@ch-metropole-savoie.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 27, 2018

Study Start

January 30, 2018

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)