Clinical trial NCT02678559: Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
Official title: Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Bypass
Hypovolemia
Anesthesia, General
Pulmonary Atelectasis
Keywords: Alveolar recruitment manoeuvre
Lung recruitment
Preload dependency
Cardiac surgery
Transoesophageal echocardiography
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Variation of stroke volume
timeFrame: at the beginning of cardiac surgery
Secondary outcomes:
measure: Velocity time integral (cm)
timeFrame: at the begining of cardiac surgery
measure: Velocity time integral (cm)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Velocity time integral (cm)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Cardiac index (l/min/m2)
timeFrame: at the begining of cardiac surgery
measure: Cardiac index (l/min/m2)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Cardiac index (l/min/m2)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Right ventricle diameter/left ventricle diameter ratio
timeFrame: at the begining of cardiac surgery
measure: Right ventricle diameter/left ventricle diameter ratio
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Right ventricle diameter/left ventricle diameter ratio
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: E/A ratio
timeFrame: at the begining of cardiac surgery
measure: E/A ratio
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: E/A ratio
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Sus-hepatic vein Doppler profile
timeFrame: at the begining of cardiac surgery
measure: Sus-hepatic vein Doppler profile
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Sus-hepatic vein Doppler profile
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Invasive arterial pressure (mmHg)
timeFrame: at the begining of cardiac surgery
measure: Invasive arterial pressure (mmHg)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Invasive arterial pressure (mmHg)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Heart rate (pulse/min)
timeFrame: at the begining of cardiac surgery
measure: Heart rate (pulse/min)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Heart rate (pulse/min)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Expired CO2 (mmHg)
timeFrame: at the begining of cardiac surgery
measure: Expired CO2 (mmHg)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Expired CO2 (mmHg)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Central venous pressure (mmHg)
timeFrame: at the begining of cardiac surgery
measure: Central venous pressure (mmHg)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Central venous pressure (mmHg)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Pulse pressure variation (%)
timeFrame: at the begining of cardiac surgery
measure: Pulse pressure variation (%)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Pulse pressure variation (%)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Perfusion index (pulsoxymeter)
timeFrame: at the begining of cardiac surgery
measure: Perfusion index (pulsoxymeter)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Perfusion index (pulsoxymeter)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Stroke volume (ml) (Flotrac measurement)
timeFrame: at the begining of cardiac surgery
measure: Stroke volume (ml) (Flotrac measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Stroke volume (ml) (Flotrac measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Stroke volume variation (%) (Flotrac measurement)
timeFrame: at the begining of cardiac surgery
measure: Stroke volume variation (%) (Flotrac measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Stroke volume variation (%) (Flotrac measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Cardiac index (l/min/m2) (Flotrac measurement)
timeFrame: at the begining of cardiac surgery
measure: Cardiac index (l/min/m2) (Flotrac measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Cardiac index (l/min/m2) (Flotrac measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Pulse pressure variation (%) (Flotrac measurement)
timeFrame: at the begining of cardiac surgery
measure: Pulse pressure variation (%) (Flotrac measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Pulse pressure variation (%) (Flotrac measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Arterial pressure (mmHg) (Flotrac measurement)
timeFrame: at the begining of cardiac surgery
measure: Arterial pressure (mmHg) (Flotrac measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Arterial pressure (mmHg) (Flotrac measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Stroke volume (ml) (Clearsight measurement)
timeFrame: at the begining of cardiac surgery
measure: Stroke volume (ml) (Clearsight measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Stroke volume (ml) (Clearsight measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Stroke volume variation (%) (Clearsight measurement)
timeFrame: at the begining of cardiac surgery
measure: Stroke volume variation (%) (Clearsight measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Stroke volume variation (%) (Clearsight measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Cardiac index (l/min/m2) (Clearsight measurement)
timeFrame: at the begining of cardiac surgery
measure: Cardiac index (l/min/m2) (Clearsight measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Cardiac index (l/min/m2) (Clearsight measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Pulse pressure variation (%) (Clearsight measurement)
timeFrame: at the begining of cardiac surgery
measure: Pulse pressure variation (%) (Clearsight measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Pulse pressure variation (%) (Clearsight measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Arterial pressure (mmHg) (Clearsight measurement)
timeFrame: at the begining of cardiac surgery
measure: Arterial pressure (mmHg) (Clearsight measurement)
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Arterial pressure (mmHg) (Clearsight measurement)
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
measure: Near infrared spectroscopy : Cerebral SrO2
timeFrame: at the begining of cardiac surgery
measure: Near infrared spectroscopy : Cerebral SrO2
timeFrame: After fluid challenges until patient is on a preload independency state.
measure: Near infrared spectroscopy : Cerebral SrO2
timeFrame: After the cardiopulmonary bypass period, when sternotomy will be closed
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: