CO2 Field Saturating Alternative Techniques Comparison

NCT03961425 | Completed

• 1 other identifier: 2019-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Embolism Air Post-Procedural

Outcome Measures

Primary Outcomes (1)

• Time to Complete Deairing

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

  Intraoperative

Secondary Outcomes (1)

• Neurological Events at Wake Up

  The day after operation

Study Arms (3)

NO CO2

ACTIVE COMPARATOR

Traditional De Airing maneuver

Behavioral: NO CO2

CO2 Cannula

ACTIVE COMPARATOR

CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula

Device: CO2 Cannula

CO2 Cardia

ACTIVE COMPARATOR

CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia

Device: CO2 Cardia

Interventions

NO CO2 BEHAVIORAL

Traditional mechanical Deairing

NO CO2

CO2 Cannula DEVICE

NON specific, low cost delivery system

Also known as: NON specific, low cost delivery system

CO2 Cannula

CO2 Cardia DEVICE

Specific Commercial CO2 Diffuser

Also known as: Specific Commercial CO2 Diffuser

CO2 Cardia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

You may not qualify if:

• any other kind of operation
• Urgency

Sponsors & Collaborators

• Cardiochirurgia E.H.: lead

Study Sites (1)

Cardiochirurgia European Hospital

Rome, 00152, Italy

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Luca Weltert, MD

  European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical Outcomes are assessed by ICU physicians and the intraoperative strategy is not disclosed
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biostatistics, Heart Surgeon

Model Details: Random allocation in 1:1:1 to either NO CO2, CO2 with non specific cannula, CO2 with dedicated diffuser

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: June 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 15, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)