Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.
| Registry | NCT03961425 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, factorial, masking: single, prevention |
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| Enrollment | 180 (Actual) |
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| Sponsor | Cardiochirurgia E.H. (Other) |
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| Conditions | Embolism Air Post-Procedural |
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| Interventions | NO CO2, CO2 Cannula, CO2 Cardia (Behavioral, device) |
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| Dates | start 2019-06-01, primary completion 2021-07-01, completion 2021-07-15, first posted 2019-05-23, last updated 2021-07-27 |
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| Locations | 1 site in Italy |
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Related Papers Related Patents Related Grants Related Experts
All trials for Embolism Air Post-Procedural All trials of NO CO2 All trials of CO2 Cannula
-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
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| NO CO2 | Active comparator | Behavioral: NO CO2 | Traditional De Airing maneuver |
| CO2 Cannula | Active comparator | Device: CO2 Cannula | CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula |
| CO2 Cardia | Active comparator | Device: CO2 Cardia | CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia |
- NO CO2 (Behavioral): Traditional mechanical Deairing
- CO2 Cannula (Device), also known as NON specific, low cost delivery system: NON specific, low cost delivery system
- CO2 Cardia (Device), also known as Specific Commercial CO2 Diffuser: Specific Commercial CO2 Diffuser
+Outcome measures
Primary outcomes
- Time to Complete Deairing [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]: Either Convulsions, Transitory Ischemic Attack or Full Stroke
+Eligibility
Sex: All
Inclusion Criteria:
Isolated, Elective Aortic Valve Replacement or combined AVR and CABG
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Exclusion Criteria:
* any other kind of operation
* Urgency
+Locations (1)
| Facility | City | Country | Status |
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| Cardiochirurgia European Hospital | Rome | Italy | |
+Publications
- 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. PMID 30654802
- 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. PMID 30288036
- 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. PMID 29195572
- 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. PMID 25939908
- 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. PMID 22917826
- 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. PMID 22578685
- Al-Rashidi F, Landenhed M, Blomquist S, Hoglund 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. PMID 20817209
- 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. PMID 18222261
+Investigators
- Luca Weltert, MD, Principal investigator, European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics