CO2 Field Saturating Alternative Techniques Comparison

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03961425

Enrollment

180

Registered

2019-05-23

Start date

2019-06-01

Completion date

2021-07-15

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism Air Post-Procedural

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.

Interventions

BEHAVIORALNO CO2

Traditional mechanical Deairing

DEVICECO2 Cannula

NON specific, low cost delivery system

DEVICECO2 Cardia

Specific Commercial CO2 Diffuser

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

Clinical Outcomes are assessed by ICU physicians and the intraoperative strategy is not disclosed

Intervention model description

Random allocation in 1:1:1 to either NO CO2, CO2 with non specific cannula, CO2 with dedicated diffuser

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG \-

Exclusion criteria

* any other kind of operation * Urgency

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026