Back to resultsCO2 Field Saturating Alternative Techniques Comparison
Primary Purpose
Embolism Air Post-Procedural
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
NO CO2
CO2 Cannula
CO2 Cardia
Sponsored by
About this trial
This is an interventional prevention trial for Embolism Air Post-Procedural
Eligibility Criteria
Inclusion Criteria:
Isolated, Elective Aortic Valve Replacement or combined AVR and CABG
-
Exclusion Criteria:
- any other kind of operation
- Urgency
Sites / Locations
- Cardiochirurgia European Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
NO CO2
CO2 Cannula
CO2 Cardia
Arm Description
Traditional De Airing maneuver
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia
Outcomes
Primary Outcome Measures
Time to Complete Deairing
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
Secondary Outcome Measures
Neurological Events at Wake Up
Either Convulsions, Transitory Ischemic Attack or Full Stroke
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03961425
Brief Title
CO2 Field Saturating Alternative Techniques Comparison
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiochirurgia E.H.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism Air Post-Procedural
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Random allocation in 1:1:1 to either NO CO2, CO2 with non specific cannula, CO2 with dedicated diffuser
Masking
Outcomes Assessor
Masking Description
Clinical Outcomes are assessed by ICU physicians and the intraoperative strategy is not disclosed
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NO CO2
Arm Type
Active Comparator
Arm Description
Traditional De Airing maneuver
Arm Title
CO2 Cannula
Arm Type
Active Comparator
Arm Description
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula
Arm Title
CO2 Cardia
Arm Type
Active Comparator
Arm Description
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia
Intervention Type
Behavioral
Intervention Name(s)
NO CO2
Intervention Description
Traditional mechanical Deairing
Intervention Type
Device
Intervention Name(s)
CO2 Cannula
Other Intervention Name(s)
NON specific, low cost delivery system
Intervention Description
NON specific, low cost delivery system
Intervention Type
Device
Intervention Name(s)
CO2 Cardia
Other Intervention Name(s)
Specific Commercial CO2 Diffuser
Intervention Description
Specific Commercial CO2 Diffuser
Primary Outcome Measure Information:
Title
Time to Complete Deairing
Description
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Neurological Events at Wake Up
Description
Either Convulsions, Transitory Ischemic Attack or Full Stroke
Time Frame
The day after operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated, Elective Aortic Valve Replacement or combined AVR and CABG
-
Exclusion Criteria:
any other kind of operation
Urgency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Weltert, MD
Organizational Affiliation
European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiochirurgia European Hospital
City
Rome
ZIP/Postal Code
00152
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30654802
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.
Results Reference
background
PubMed Identifier
30288036
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.
Results Reference
background
PubMed Identifier
29195572
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.
Results Reference
background
PubMed Identifier
25939908
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.
Results Reference
background
PubMed Identifier
22917826
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.
Results Reference
background
PubMed Identifier
22578685
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.
Results Reference
background
PubMed Identifier
20817209
Citation
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.
Results Reference
background
PubMed Identifier
18222261
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.
Results Reference
background
Learn more about this trial
CO2 Field Saturating Alternative Techniques Comparison
We'll reach out to this number within 24 hrs