Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres (PreDeARM)

April 19, 2017 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Population studied: anesthetized patients for cardiac surgery of coronary bypass.

Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)

- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation

Study Type

Interventional

Enrollment (Actual)

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 Locations

France
- - Clermont-Ferrand, France, 63003
    - Chu Clermont-Ferrand

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Non-Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEE monitory system comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.	Other: tee measurement Other: flotrac measurement Other: clearsight measurement
Experimental: mini-invasive monitoring system comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.	Other: tee measurement Other: flotrac measurement Other: clearsight measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of stroke volume Time Frame: at the beginning of cardiac surgery	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 Outcome Measures

Collaborators and Investigators

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

Sponsor

University Hospital, Clermont-Ferrand

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)

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CHU-0254

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.

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Outcome Measure	Measure Description	Time Frame
Velocity time integral (cm) Time Frame: at the begining of cardiac surgery	Velocity time integral (cm) (TEE measurement)	at the begining of cardiac surgery
Velocity time integral (cm) Time Frame: After fluid challenges until patient is on a preload independency state.	Velocity time integral (cm) (TEE measurement)	After fluid challenges until patient is on a preload independency state.
Velocity time integral (cm) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed	Velocity time integral (cm) (TEE measurement)	After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2) Time Frame: at the begining of cardiac surgery	Cardiac index (l/min/m2) (TEE measurement)	at the begining of cardiac surgery
Cardiac index (l/min/m2) Time Frame: After fluid challenges until patient is on a preload independency state.	Cardiac index (l/min/m2) (TEE measurement)	After fluid challenges until patient is on a preload independency state.
Cardiac index (l/min/m2) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed	Cardiac index (l/min/m2) (TEE measurement)	After the cardiopulmonary bypass period, when sternotomy will be closed
Right ventricle diameter/left ventricle diameter ratio Time Frame: at the begining of cardiac surgery	Right ventricle diameter/left ventricle diameter ratio (TEE measurement),	at the begining of cardiac surgery
Right ventricle diameter/left ventricle diameter ratio Time Frame: After fluid challenges until patient is on a preload independency state.	Right ventricle diameter/left ventricle diameter ratio (TEE measurement),	After fluid challenges until patient is on a preload independency state.
Right ventricle diameter/left ventricle diameter ratio Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed	Right ventricle diameter/left ventricle diameter ratio (TEE measurement),	After the cardiopulmonary bypass period, when sternotomy will be closed
E/A ratio Time Frame: at the begining of cardiac surgery	E/A ratio (TEE measurement)	at the begining of cardiac surgery
E/A ratio Time Frame: After fluid challenges until patient is on a preload independency state.	E/A ratio (TEE measurement)	After fluid challenges until patient is on a preload independency state.
E/A ratio Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed	E/A ratio (TEE measurement)	After the cardiopulmonary bypass period, when sternotomy will be closed
Sus-hepatic vein Doppler profile Time Frame: at the begining of cardiac surgery	Sus-hepatic vein Doppler profile (TEE measurement)	at the begining of cardiac surgery
Sus-hepatic vein Doppler profile Time Frame: After fluid challenges until patient is on a preload independency state.	Sus-hepatic vein Doppler profile (TEE measurement)	After fluid challenges until patient is on a preload independency state.
Sus-hepatic vein Doppler profile Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed	Sus-hepatic vein Doppler profile (TEE measurement)	After the cardiopulmonary bypass period, when sternotomy will be closed
Invasive arterial pressure (mmHg) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Invasive arterial pressure (mmHg) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Invasive arterial pressure (mmHg) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Heart rate (pulse/min) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Heart rate (pulse/min) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Heart rate (pulse/min) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Expired CO2 (mmHg) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Expired CO2 (mmHg) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Expired CO2 (mmHg) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Central venous pressure (mmHg) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Central venous pressure (mmHg) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Central venous pressure (mmHg) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Pulse pressure variation (%) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Pulse pressure variation (%) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Pulse pressure variation (%) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Perfusion index (pulsoxymeter) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Perfusion index (pulsoxymeter) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Perfusion index (pulsoxymeter) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume (ml) (Flotrac measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Stroke volume (ml) (Flotrac measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Stroke volume (ml) (Flotrac measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume variation (%) (Flotrac measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Stroke volume variation (%) (Flotrac measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Stroke volume variation (%) (Flotrac measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2) (Flotrac measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Cardiac index (l/min/m2) (Flotrac measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Cardiac index (l/min/m2) (Flotrac measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Pulse pressure variation (%) (Flotrac measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Pulse pressure variation (%) (Flotrac measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Pulse pressure variation (%) (Flotrac measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Arterial pressure (mmHg) (Flotrac measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Arterial pressure (mmHg) (Flotrac measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Arterial pressure (mmHg) (Flotrac measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume (ml) (Clearsight measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Stroke volume (ml) (Clearsight measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Stroke volume (ml) (Clearsight measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume variation (%) (Clearsight measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Stroke volume variation (%) (Clearsight measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Stroke volume variation (%) (Clearsight measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2) (Clearsight measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Cardiac index (l/min/m2) (Clearsight measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Cardiac index (l/min/m2) (Clearsight measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Pulse pressure variation (%) (Clearsight measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Pulse pressure variation (%) (Clearsight measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Pulse pressure variation (%) (Clearsight measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Arterial pressure (mmHg) (Clearsight measurement) Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Arterial pressure (mmHg) (Clearsight measurement) Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Arterial pressure (mmHg) (Clearsight measurement) Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed
Near infrared spectroscopy : Cerebral SrO2 Time Frame: at the begining of cardiac surgery		at the begining of cardiac surgery
Near infrared spectroscopy : Cerebral SrO2 Time Frame: After fluid challenges until patient is on a preload independency state.		After fluid challenges until patient is on a preload independency state.
Near infrared spectroscopy : Cerebral SrO2 Time Frame: After the cardiopulmonary bypass period, when sternotomy will be closed		After the cardiopulmonary bypass period, when sternotomy will be closed

Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres (PreDeARM)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Coronary Artery Disease

Clinical Trials on tee measurement

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