NCT03961425

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Cardiochirurgia E.H. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Embolism Air Post-Procedural

Interventions

Type	Name	Description
BEHAVIORAL	NO CO2	Traditional mechanical Deairing
DEVICE	CO2 Cannula	NON specific, low cost delivery system
DEVICE	CO2 Cardia	Specific Commercial CO2 Diffuser

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-07-01
• Completion: 2021-07-15
• First posted: 2019-05-23
• Last updated: 2021-07-27

Locations

1 site across 1 country: Italy