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OpenTrials
Completed

NCT Number: NCT03961425

CO2 Field Saturating Alternative Techniques Comparison

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

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Key information

Conditions

Embolism Air Post-Procedural

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiochirurgia European Hospital

Rome, 00152, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

-

Exclusion criteria

  • any other kind of operation
  • Urgency

Treatment and study plan

NO CO2

Behavioral

Traditional mechanical Deairing

CO2 Cannula

Device

NON specific, low cost delivery system

Other names: NON specific, low cost delivery system

CO2 Cardia

Device

Specific Commercial CO2 Diffuser

Other names: Specific Commercial CO2 Diffuser

Primary outcomes

  1. Time to Complete Deairing

    Time frame: Intraoperative

    Number of seconds since Declamping until no more air bubbles are visible on TEE Echo

Secondary outcomes

  1. Neurological Events at Wake Up

    Time frame: The day after operation

    Either Convulsions, Transitory Ischemic Attack or Full Stroke

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 23, 2019
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.