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

Primary Purpose

Coronary Artery Disease, Coronary Artery Bypass, Hypovolemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tee measurement
flotrac measurement
clearsight measurement
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Alveolar recruitment manoeuvre, Lung recruitment, Preload dependency, Cardiac surgery, Transoesophageal echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TEE monitory system

mini-invasive monitoring system

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Velocity time integral (cm)
Velocity time integral (cm) (TEE measurement)
Velocity time integral (cm)
Velocity time integral (cm) (TEE measurement)
Velocity time integral (cm)
Velocity time integral (cm) (TEE measurement)
Cardiac index (l/min/m2)
Cardiac index (l/min/m2) (TEE measurement)
Cardiac index (l/min/m2)
Cardiac index (l/min/m2) (TEE measurement)
Cardiac index (l/min/m2)
Cardiac index (l/min/m2) (TEE measurement)
Right ventricle diameter/left ventricle diameter ratio
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Right ventricle diameter/left ventricle diameter ratio
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Right ventricle diameter/left ventricle diameter ratio
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
E/A ratio
E/A ratio (TEE measurement)
E/A ratio
E/A ratio (TEE measurement)
E/A ratio
E/A ratio (TEE measurement)
Sus-hepatic vein Doppler profile
Sus-hepatic vein Doppler profile (TEE measurement)
Sus-hepatic vein Doppler profile
Sus-hepatic vein Doppler profile (TEE measurement)
Sus-hepatic vein Doppler profile
Sus-hepatic vein Doppler profile (TEE measurement)
Invasive arterial pressure (mmHg)
Invasive arterial pressure (mmHg)
Invasive arterial pressure (mmHg)
Heart rate (pulse/min)
Heart rate (pulse/min)
Heart rate (pulse/min)
Expired CO2 (mmHg)
Expired CO2 (mmHg)
Expired CO2 (mmHg)
Central venous pressure (mmHg)
Central venous pressure (mmHg)
Central venous pressure (mmHg)
Pulse pressure variation (%)
Pulse pressure variation (%)
Pulse pressure variation (%)
Perfusion index (pulsoxymeter)
Perfusion index (pulsoxymeter)
Perfusion index (pulsoxymeter)
Stroke volume (ml) (Flotrac measurement)
Stroke volume (ml) (Flotrac measurement)
Stroke volume (ml) (Flotrac measurement)
Stroke volume variation (%) (Flotrac measurement)
Stroke volume variation (%) (Flotrac measurement)
Stroke volume variation (%) (Flotrac measurement)
Cardiac index (l/min/m2) (Flotrac measurement)
Cardiac index (l/min/m2) (Flotrac measurement)
Cardiac index (l/min/m2) (Flotrac measurement)
Pulse pressure variation (%) (Flotrac measurement)
Pulse pressure variation (%) (Flotrac measurement)
Pulse pressure variation (%) (Flotrac measurement)
Arterial pressure (mmHg) (Flotrac measurement)
Arterial pressure (mmHg) (Flotrac measurement)
Arterial pressure (mmHg) (Flotrac measurement)
Stroke volume (ml) (Clearsight measurement)
Stroke volume (ml) (Clearsight measurement)
Stroke volume (ml) (Clearsight measurement)
Stroke volume variation (%) (Clearsight measurement)
Stroke volume variation (%) (Clearsight measurement)
Stroke volume variation (%) (Clearsight measurement)
Cardiac index (l/min/m2) (Clearsight measurement)
Cardiac index (l/min/m2) (Clearsight measurement)
Cardiac index (l/min/m2) (Clearsight measurement)
Pulse pressure variation (%) (Clearsight measurement)
Pulse pressure variation (%) (Clearsight measurement)
Pulse pressure variation (%) (Clearsight measurement)
Arterial pressure (mmHg) (Clearsight measurement)
Arterial pressure (mmHg) (Clearsight measurement)
Arterial pressure (mmHg) (Clearsight measurement)
Near infrared spectroscopy : Cerebral SrO2
Near infrared spectroscopy : Cerebral SrO2
Near infrared spectroscopy : Cerebral SrO2

Full Information

First Posted
January 15, 2016
Last Updated
April 19, 2017
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT02678559
Brief Title
Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
Acronym
PreDeARM
Official Title
Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Bypass, Hypovolemia, Anesthesia, General, Pulmonary Atelectasis
Keywords
Alveolar recruitment manoeuvre, Lung recruitment, Preload dependency, Cardiac surgery, Transoesophageal echocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEE monitory system
Arm Type
Experimental
Arm Description
comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
Arm Title
mini-invasive monitoring system
Arm Type
Experimental
Arm Description
comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
Intervention Type
Other
Intervention Name(s)
tee measurement
Intervention Type
Other
Intervention Name(s)
flotrac measurement
Intervention Type
Other
Intervention Name(s)
clearsight measurement
Primary Outcome Measure Information:
Title
Variation of stroke volume
Description
Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery
Time Frame
at the beginning of cardiac surgery
Secondary Outcome Measure Information:
Title
Velocity time integral (cm)
Description
Velocity time integral (cm) (TEE measurement)
Time Frame
at the begining of cardiac surgery
Title
Velocity time integral (cm)
Description
Velocity time integral (cm) (TEE measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Velocity time integral (cm)
Description
Velocity time integral (cm) (TEE measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Cardiac index (l/min/m2)
Description
Cardiac index (l/min/m2) (TEE measurement)
Time Frame
at the begining of cardiac surgery
Title
Cardiac index (l/min/m2)
Description
Cardiac index (l/min/m2) (TEE measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Cardiac index (l/min/m2)
Description
Cardiac index (l/min/m2) (TEE measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Right ventricle diameter/left ventricle diameter ratio
Description
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Time Frame
at the begining of cardiac surgery
Title
Right ventricle diameter/left ventricle diameter ratio
Description
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Right ventricle diameter/left ventricle diameter ratio
Description
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
E/A ratio
Description
E/A ratio (TEE measurement)
Time Frame
at the begining of cardiac surgery
Title
E/A ratio
Description
E/A ratio (TEE measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
E/A ratio
Description
E/A ratio (TEE measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Sus-hepatic vein Doppler profile
Description
Sus-hepatic vein Doppler profile (TEE measurement)
Time Frame
at the begining of cardiac surgery
Title
Sus-hepatic vein Doppler profile
Description
Sus-hepatic vein Doppler profile (TEE measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Sus-hepatic vein Doppler profile
Description
Sus-hepatic vein Doppler profile (TEE measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Invasive arterial pressure (mmHg)
Time Frame
at the begining of cardiac surgery
Title
Invasive arterial pressure (mmHg)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Invasive arterial pressure (mmHg)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Heart rate (pulse/min)
Time Frame
at the begining of cardiac surgery
Title
Heart rate (pulse/min)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Heart rate (pulse/min)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Expired CO2 (mmHg)
Time Frame
at the begining of cardiac surgery
Title
Expired CO2 (mmHg)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Expired CO2 (mmHg)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Central venous pressure (mmHg)
Time Frame
at the begining of cardiac surgery
Title
Central venous pressure (mmHg)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Central venous pressure (mmHg)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Pulse pressure variation (%)
Time Frame
at the begining of cardiac surgery
Title
Pulse pressure variation (%)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Pulse pressure variation (%)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Perfusion index (pulsoxymeter)
Time Frame
at the begining of cardiac surgery
Title
Perfusion index (pulsoxymeter)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Perfusion index (pulsoxymeter)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Stroke volume (ml) (Flotrac measurement)
Time Frame
at the begining of cardiac surgery
Title
Stroke volume (ml) (Flotrac measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Stroke volume (ml) (Flotrac measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Stroke volume variation (%) (Flotrac measurement)
Time Frame
at the begining of cardiac surgery
Title
Stroke volume variation (%) (Flotrac measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Stroke volume variation (%) (Flotrac measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Cardiac index (l/min/m2) (Flotrac measurement)
Time Frame
at the begining of cardiac surgery
Title
Cardiac index (l/min/m2) (Flotrac measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Cardiac index (l/min/m2) (Flotrac measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Pulse pressure variation (%) (Flotrac measurement)
Time Frame
at the begining of cardiac surgery
Title
Pulse pressure variation (%) (Flotrac measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Pulse pressure variation (%) (Flotrac measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Arterial pressure (mmHg) (Flotrac measurement)
Time Frame
at the begining of cardiac surgery
Title
Arterial pressure (mmHg) (Flotrac measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Arterial pressure (mmHg) (Flotrac measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Stroke volume (ml) (Clearsight measurement)
Time Frame
at the begining of cardiac surgery
Title
Stroke volume (ml) (Clearsight measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Stroke volume (ml) (Clearsight measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Stroke volume variation (%) (Clearsight measurement)
Time Frame
at the begining of cardiac surgery
Title
Stroke volume variation (%) (Clearsight measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Stroke volume variation (%) (Clearsight measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Cardiac index (l/min/m2) (Clearsight measurement)
Time Frame
at the begining of cardiac surgery
Title
Cardiac index (l/min/m2) (Clearsight measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Cardiac index (l/min/m2) (Clearsight measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Pulse pressure variation (%) (Clearsight measurement)
Time Frame
at the begining of cardiac surgery
Title
Pulse pressure variation (%) (Clearsight measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Pulse pressure variation (%) (Clearsight measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Arterial pressure (mmHg) (Clearsight measurement)
Time Frame
at the begining of cardiac surgery
Title
Arterial pressure (mmHg) (Clearsight measurement)
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Arterial pressure (mmHg) (Clearsight measurement)
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed
Title
Near infrared spectroscopy : Cerebral SrO2
Time Frame
at the begining of cardiac surgery
Title
Near infrared spectroscopy : Cerebral SrO2
Time Frame
After fluid challenges until patient is on a preload independency state.
Title
Near infrared spectroscopy : Cerebral SrO2
Time Frame
After the cardiopulmonary bypass period, when sternotomy will be closed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

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