Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

Coronary Artery Disease Clinical Trial

— PreDeARM  

Official title:

Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678559
• Other study ID #: CHU-0254
• Status: Completed
• Phase: N/A
• First received: January 15, 2016
• Last updated: April 19, 2017
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General
• Coronary Artery Bypass
• Coronary Artery Disease
• Coronary Disease
• Hypovolemia
• Myocardial Ischemia
• Pulmonary Atelectasis

Intervention

Other:
• tee measurement

• flotrac measurement

• clearsight measurement

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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