CO2 Field Saturating Alternative Techniques Comparison

Embolism Air Post-Procedural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961425
• Other study ID #: 2019-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: July 2021
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 15, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

-

Exclusion Criteria:

• any other kind of operation

• Urgency

Related Conditions & MeSH terms

• Embolism
• Embolism Air Post-Procedural

Intervention

Behavioral:
• NO CO2
Traditional mechanical Deairing

Device:
• CO2 Cannula
NON specific, low cost delivery system
• CO2 Cardia
Specific Commercial CO2 Diffuser

Locations

Country	Name	City	State
Italy	Cardiochirurgia European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Al-Rashidi F, Landenhed M, Blomquist S, Höglund P, Karlsson PA, Pierre L, Koul B. Comparison of the effectiveness and safety of a new de-airing technique with a standardized carbon dioxide insufflation technique in open left heart surgery: a randomized clinical trial. J Thorac Cardiovasc Surg. 2011 May;141(5):1128-33. doi: 10.1016/j.jtcvs.2010.07.013. Epub 2010 Sep 3. — View Citation

Benedetto U, Caputo M, Guida G, Bucciarelli-Ducci C, Thai J, Bryan A, Angelini GD. Carbon Dioxide Insufflation During Cardiac Surgery: A Meta-analysis of Randomized Controlled Trials. Semin Thorac Cardiovasc Surg. 2017 Autumn;29(3):301-310. doi: 10.1053/j.semtcvs.2017.05.002. Epub 2017 May 23. Review. — View Citation

Chatterjee S, Greenberg SB, Brown J, Murphy GS, Pearson PJ, Alexander JC. Simple technique to verify CO(2) diffusion with the CarbonAid™ device. Heart Surg Forum. 2012 Aug;15(4):E212-4. doi: 10.1532/HSF98.20121015. — View Citation

Chaudhuri K, Storey E, Lee GA, Bailey M, Chan J, Rosenfeldt FL, Pick A, Negri J, Gooi J, Zimmet A, Esmore D, Merry C, Rowland M, Lin E, Marasco SF. Carbon dioxide insufflation in open-chamber cardiac surgery: a double-blind, randomized clinical trial of neurocognitive effects. J Thorac Cardiovasc Surg. 2012 Sep;144(3):646-653.e1. doi: 10.1016/j.jtcvs.2012.04.010. Epub 2012 May 12. — View Citation

Ganguly G, Dixit V, Patrikar S, Venkatraman R, Gorthi SP, Tiwari N. Carbon dioxide insufflation and neurocognitive outcome of open heart surgery. Asian Cardiovasc Thorac Ann. 2015 Sep;23(7):774-80. doi: 10.1177/0218492315583562. Epub 2015 May 4. — View Citation

Listewnik M, Kotfis K, Slozowski P, Mokrzycki K, Brykczynski M. The influence of carbon dioxide field flooding in mitral valve operations with cardiopulmonary bypass on S100ß level in blood plasma in the aging brain. Clin Interv Aging. 2018 Sep 25;13:1837-1845. doi: 10.2147/CIA.S177356. eCollection 2018. — View Citation

Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047. — View Citation

Nyman J, Svenarud P, van der Linden J. Carbon dioxide de-airing in minimal invasive cardiac surgery, a new effective device. J Cardiothorac Surg. 2019 Jan 17;14(1):12. doi: 10.1186/s13019-018-0824-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Deairing	Number of seconds since Declamping until no more air bubbles are visible on TEE Echo	Intraoperative
Secondary	Neurological Events at Wake Up	Either Convulsions, Transitory Ischemic Attack or Full Stroke	The day after operation