CO2 Field Saturating Alternative Techniques Comparison

July 26, 2021 updated by: Luca Weltert, Cardiochirurgia E.H.

Cardia Carbonaid VS Standard Cannula VS NO CO2 Approach: Impact on Time to Complete Deairing and Clinical Neurological Events; a Randomized Prospective Study.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00152
        • Cardiochirurgia European Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Isolated, Elective Aortic Valve Replacement or combined AVR and CABG

-

Exclusion Criteria:

  • any other kind of operation
  • Urgency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Specific Commercial CO2 Diffuser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Complete Deairing
Time Frame: Intraoperative
Number of seconds since Declamping until no more air bubbles are visible on TEE Echo
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological Events at Wake Up
Time Frame: The day after operation
Either Convulsions, Transitory Ischemic Attack or Full Stroke
The day after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiochirurgia E.H.

Investigators

  • Principal Investigator: Luca Weltert, MD, European Hospital HEart Surgeon - Unicamillus Professor of Biostatistics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01 (Other Identifier: NANT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Embolism Air Post-Procedural

Clinical Trials on NO CO2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe