CO2 Field Saturating Alternative Techniques Comparison

Not Applicable

Completed

• Conditions: Embolism Air Post-Procedural
• Interventions: Behavioral: NO CO2; Device: CO2 Cardia; Device: CO2 Cannula

• Registration Number: NCT03961425
• Lead Sponsor: Cardiochirurgia E.H.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Study Start: 2019-06-01
• Status Verified: 2021-07
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-15
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

Exclusion Criteria

• any other kind of operation
• Urgency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
NO CO2	NO CO2	Traditional De Airing maneuver
CO2 Cardia	CO2 Cardia	CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia
CO2 Cannula	CO2 Cannula	CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula

Primary Outcome Measures

Name	Time	Method
Time to Complete Deairing	Intraoperative	Number of seconds since Declamping until no more air bubbles are visible on TEE Echo

Secondary Outcome Measures

Name	Time	Method
Neurological Events at Wake Up	The day after operation	Either Convulsions, Transitory Ischemic Attack or Full Stroke

Trial Locations

Locations (1)

Cardiochirurgia European Hospital; 🇮🇹 Rome, Italy