CO2 Field Saturating Alternative Techniques Comparison

Cardiochirurgia E.H.

Status: Completed

Conditions: Embolism Air Post-Procedural

Treatments: Device: CO2 Cardia; Behavioral: NO CO2; Device: CO2 Cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT03961425

2019-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 180 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

Exclusion criteria

• any other kind of operation
• Urgency

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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180 participants in 3 patient groups

NO CO2

Active Comparator group

Description:

Traditional De Airing maneuver

Treatment:

Behavioral: NO CO2

CO2 Cannula

Active Comparator group

Description:

CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula

Treatment:

Device: CO2 Cannula

CO2 Cardia

Active Comparator group

Description:

CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia

Treatment:

Device: CO2 Cardia