CO2 Field Saturating Alternative Techniques Comparison

Study Overview
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Brief Summary
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Prospective Randomized study comparing three strategy of deairing (NO CO2 insufflation, CO2 insufflation with non specific cannula, CO2 insufflation with commercial dedicated diffuser) as regarding Time to Complete Deairing measured from declamping via TEE Echo and Neurological Events at Wake Up

Detailed Description
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The impact of air bubbles into the cerebral circulation after open heart surgery has been a topic of discussion since the introduction of the heart-lung machine, and flooding the surgical field with CO2, which is heavier than Azote and Oxygen but over ten times more soluble seems a promising technique to minimize the presence of air microemboli. However very few studies have been conducted to ascertain what is the most efficient way to administer this treatment, or even of this treatment really impacts deairing time and clinical neurological events. This study aims at comparing the use of CO2 (administered in two different ways: a simple cannula, which might be prone to emulsioning air and CO2 not reaching a complete CO2 saturation and a specific commercial diffuser which states promises complete filed saturation) to the no-CO2 standard approach. The primary end point will be Time to Complete deairing as measured by intraoperative transesophageal echo while the secondary end point will be the incidence of clinical neurological events the day after the operation.

Official Title
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Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.

Conditions
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Embolism Air Post-Procedural

Intervention / Treatment
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* Behavioral: NO CO2
* Device: CO2 Cannula
* Device: CO2 Cardia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated, Elective Aortic Valve Replacement or combined AVR and CABG - Exclusion Criteria: any other kind of operation Urgency
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Random allocation in 1:1:1 to either NO CO2, CO2 with non specific cannula, CO2 with dedicated diffuser
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NO CO2<br>Traditional De Airing maneuver | Behavioral: NO CO2<br>* Traditional mechanical Deairing<br>|
| Active Comparator: CO2 Cannula<br>CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula | Device: CO2 Cannula<br>* NON specific, low cost delivery system<br>* Other names: NON specific, low cost delivery system;|
| Active Comparator: CO2 Cardia<br>CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia | Device: CO2 Cardia<br>* Specific Commercial CO2 Diffuser<br>* Other names: Specific Commercial CO2 Diffuser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Deairing | Number of seconds since Declamping until no more air bubbles are visible on TEE Echo | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Events at Wake Up | Either Convulsions, Transitory Ischemic Attack or Full Stroke | The day after operation |