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CO2 Field Saturating Alternative Techniques Comparison

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ClinicalTrials.gov Identifier: NCT03961425
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.

Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Time to Complete Deairing [ Time Frame: Intraoperative ]
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03961425 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Neurological Events at Wake Up [ Time Frame: The day after operation ]
Either Convulsions, Transitory Ischemic Attack or Full Stroke
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CO2 Field Saturating Alternative Techniques Comparison
Official Title  ICMJE Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Random allocation in 1:1:1 to either NO CO2, CO2 with non specific cannula, CO2 with dedicated diffuser
Masking: Single (Outcomes Assessor)
Masking Description:
Clinical Outcomes are assessed by ICU physicians and the intraoperative strategy is not disclosed
Primary Purpose: Prevention
Condition  ICMJE Embolism Air Post-Procedural
Intervention  ICMJE
  • Behavioral: NO CO2
    Traditional mechanical Deairing
  • Device: CO2 Cannula
    NON specific, low cost delivery system
    Other Name: NON specific, low cost delivery system
  • Device: CO2 Cardia
    Specific Commercial CO2 Diffuser
    Other Name: Specific Commercial CO2 Diffuser
Study Arms  ICMJE
  • Active Comparator: NO CO2
    Traditional De Airing maneuver
    Intervention: Behavioral: NO CO2
  • Active Comparator: CO2 Cannula
    CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula
    Intervention: Device: CO2 Cannula
  • Active Comparator: CO2 Cardia
    CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia
    Intervention: Device: CO2 Cardia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

-

Exclusion Criteria:

  • any other kind of operation
  • Urgency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Luca Weltert, MD +393478880617 lweltert@gmail.com
Contact: Ruggero De Paulis, MD rdepaulis58@gmail.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961425
Other Study ID Numbers  ICMJE 2019-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Luca Weltert, Cardiochirurgia E.H.
Study Sponsor  ICMJE Cardiochirurgia E.H.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luca Weltert, MD European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics
PRS Account Cardiochirurgia E.H.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP