NCT02678559

Brief Summary

The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

January 15, 2016

Last Update Submit

April 19, 2017

Conditions

Coronary Artery DiseaseCoronary Artery BypassHypovolemiaAnesthesia, GeneralPulmonary Atelectasis

Keywords

Alveolar recruitment manoeuvreLung recruitmentPreload dependencyCardiac surgeryTransoesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

  • Variation of stroke volume

    Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery

    at the beginning of cardiac surgery

Secondary Outcomes (66)

  • Velocity time integral (cm)

    at the begining of cardiac surgery

  • Velocity time integral (cm)

    After fluid challenges until patient is on a preload independency state.

  • Velocity time integral (cm)

    After the cardiopulmonary bypass period, when sternotomy will be closed

  • Cardiac index (l/min/m2)

    at the begining of cardiac surgery

  • Cardiac index (l/min/m2)

    After fluid challenges until patient is on a preload independency state.

  • +61 more secondary outcomes

Study Arms (2)

TEE monitory system

EXPERIMENTAL

comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.

Other: tee measurementOther: flotrac measurementOther: clearsight measurement

mini-invasive monitoring system

EXPERIMENTAL

comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.

Other: tee measurementOther: flotrac measurementOther: clearsight measurement

Interventions

tee measurementOTHER
TEE monitory systemmini-invasive monitoring system
flotrac measurementOTHER
TEE monitory systemmini-invasive monitoring system
clearsight measurementOTHER
TEE monitory systemmini-invasive monitoring system

Eligibility Criteria

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

You may qualify if:

  • Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected

You may not qualify if:

  • Emergency case
  • Pericardial effusion
  • Aortic or mitral valvulopathy
  • Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion
  • Bad echogenicity
  • Patient refusal to participate to the study
  • No health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHypovolemiaPulmonary Atelectasis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

February 10, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

FR(1)