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CO2 Field Saturating Alternative Techniques Comparison

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ClinicalTrials.gov Identifier: NCT03961425
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.

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

Condition or disease Intervention/treatment Phase
Embolism Air Post-Procedural Behavioral: NO CO2 Device: CO2 Cannula Device: CO2 Cardia Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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
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.
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NO CO2
Traditional De Airing maneuver
Behavioral: NO CO2
Traditional mechanical Deairing

Active Comparator: CO2 Cannula
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by non specific needle cannula
Device: CO2 Cannula
NON specific, low cost delivery system
Other Name: NON specific, low cost delivery system

Active Comparator: CO2 Cardia
CO2 at 8 l/min since 2 minutes before aortic cross clamp delivered by commercial diffuser Cardia
Device: CO2 Cardia
Specific Commercial CO2 Diffuser
Other Name: Specific Commercial CO2 Diffuser




Primary Outcome Measures :
  1. Time to Complete Deairing [ Time Frame: Intraoperative ]
    Number of seconds since Declamping until no more air bubbles are visible on TEE Echo


Secondary Outcome Measures :
  1. Neurological Events at Wake Up [ Time Frame: The day after operation ]
    Either Convulsions, Transitory Ischemic Attack or Full Stroke



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

-

Exclusion Criteria:

  • any other kind of operation
  • Urgency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961425


Contacts
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Contact: Luca Weltert, MD +393478880617 lweltert@gmail.com
Contact: Ruggero De Paulis, MD rdepaulis58@gmail.com

Locations
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Italy
Cardiochirurgia European Hospital
Rome, Italy, 00152
Sponsors and Collaborators
Cardiochirurgia E.H.
Investigators
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Principal Investigator: Luca Weltert, MD European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics

Publications:

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Responsible Party: Luca Weltert, Professor of Biostatistics, Heart Surgeon, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT03961425     History of Changes
Other Study ID Numbers: 2019-01
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases