Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

March 19, 2016 updated by: Meshalkin Research Institute of Pathology of Circulation

Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations

Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Arterial air embolism in cardiac surgery is not a rare complication, leading to neurological damage in the early postoperative period of 3-5%. Insufflation of carbon dioxide (CO2) into the operative field to prevent cerebral or myocardial damage by air embolism is reported since 1967 in open heart surgery (Selman MW et al. 1967).

Carbon dioxide fills the thoracic cavity by gravity and replaces air if adequately insufflated. Because solubility of CO2 is better than that of air, occlusion or flow disruption in arteries of the brain or the heart is thought to be diminished. Despite carefully performed deairing procedures as puncturing of the ascending aorta and cardiac massage, transcranial Doppler studies revealed large amounts of emboli during the first ejections of the beating heart (van der Linden J et al. 1991). In patiens with minimally invasive approach and redo valve surgery, deairing of the cardiac chambers has become more difficult.

Although the use of carbon dioxide when filling in the surgical field, as the prevention of air embolism reduces the number of intracardiac emboli according to transesophageal echocardiography there is no evidence of a sustained reduction in cerebrovascular events (G. Salvatore al. 2009).

Study Type

Interventional

Enrollment (Anticipated)

334

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

  • Russian Federation
    • Novosibirsk territory
      • Novosibirsk, Novosibirsk territory, Russian Federation, 630055
        • Recruiting
        • Novosibirsk State Research Institute of Circulation Pathology
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Michael S Fomenko

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to sign Informed Consent and Release of Medical Information forms
  • Age 18 - 70 years
  • Patients scheduled on cardiac surgery with opening cavities

Exclusion Criteria:

  • History of stroke and TIA
  • Significant carotid artery stenosis
  • Presence of initial severe encephalopathy
  • Re-clamping of the aorta
  • Emergency surgery

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: conventional prophylaxis of aeroembolism

Procedure: cardiac surgery with opening of heart chambers.

Will be including 167 patients to undergo cardiac surgery. After the main operation phase all heart cavities are sealed, left vent drainage is stopped, ascending aorta is punctured and cardiac massage is performed, ventilation is started and the heart is filled with volume. Operating table is positioned in the Trendelenburg position, and aorta is opened. The amount of air in the cavities is evaluated by transesophageal echocardiography.
Procedure: conventional prophylaxis of aeroembolism
167 patients will be enrolled. Will perform standard way of aeroembolism prevention
Procedure: cardiac surgery with opening of heart chambers
Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities
Other: conventional prophylaxis plus CO2 insufflation

Procedure: cardiac surgery with opening of heart chambers.

Will be including 167 patients to undergo cardiac surgery. After the main phase of the operation standard measures of aeroembolism prevention are carried out. The amount of air in the cavities is evaluated by transesophageal echocardiography.
Procedure: cardiac surgery with opening of heart chambers
Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities
Procedure: conventional prophylaxis plus CO2 insufflation
167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
Time Frame: 14 days
conducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
hospital mortality
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Aleksandr V Bogachev-Prokophiev, PhD, Meshalkin Research Institute of Pathology of Circulation

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

September 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 19, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-54-22

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.

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