Mitral Doppler as a Predictor of Respiratory Worsening Af... | NCT03447366

Studies
Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling

NCT03447366

Sponsor

Centre Hospitalier Metropole Savoie

Status

Completed

Last Update Posted

Jun 10, 2026Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

Respiration, Artificial
Vascular Filling
Echocardiography

Interventions

mitral doppler

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2018Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Feb 2, 2018

First Submission Date that Met QC Criteria

Feb 26, 2018

First Posted Date

Feb 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitral doppler	Experimental	Mitral doppler before and after vascular filling	Diagnostic Test: mitral doppler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitral doppler	Diagnostic Test	Mitral doppler before and after vascular filling	Mitral doppler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ch Bourg En Bresse		Bourg-en-Bresse			France
Centre Hospitalier Metropole Savoie

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided