Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Time to Complete Deairing
Study Overview
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 Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Isolated, Elective Aortic Valve Replacement or combined AVR and CABG
Exclusion Criteria
- •any other kind of operation
Arms & Interventions
NO CO2
Traditional De Airing maneuver
Intervention: NO CO2 (Behavioral)
CO2 Cannula
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula
Intervention: CO2 Cannula (Device)
CO2 Cardia
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia
Intervention: CO2 Cardia (Device)
Outcomes
Primary Outcomes
Time to Complete Deairing
Time Frame: Intraoperative
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
Secondary Outcomes
- Neurological Events at Wake Up(The day after operation)
Investigators
Luca Weltert
Professor of Biostatistics, Heart Surgeon
Cardiochirurgia E.H.