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Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

Primary Purpose

Air Embolism, Neurological Damage

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
conventional prophylaxis of aeroembolism
conventional prophylaxis plus CO2 insufflation
cardiac surgery with opening of heart chambers
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Air Embolism focused on measuring carbon dioxide, postoperative cerebrovascular complications, air embolism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novosibirsk State Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

conventional prophylaxis of aeroembolism

conventional prophylaxis plus CO2 insufflation

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

hospital mortality

Full Information

First Posted
December 16, 2014
Last Updated
March 19, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02340741
Brief Title
Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications
Official Title
Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Air Embolism, Neurological Damage
Keywords
carbon dioxide, postoperative cerebrovascular complications, air embolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional prophylaxis of aeroembolism
Arm Type
Other
Arm Description
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.
Arm Title
conventional prophylaxis plus CO2 insufflation
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional prophylaxis of aeroembolism
Intervention Description
167 patients will be enrolled. Will perform standard way of aeroembolism prevention
Intervention Type
Procedure
Intervention Name(s)
conventional prophylaxis plus CO2 insufflation
Intervention Description
167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide
Intervention Type
Procedure
Intervention Name(s)
cardiac surgery with opening of heart chambers
Intervention Description
Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities
Primary Outcome Measure Information:
Title
postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
Description
conducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
Time Frame
14 days
Secondary Outcome Measure Information:
Title
hospital mortality
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandr V Bogachev-Prokophiev, PhD
Organizational Affiliation
Meshalkin Research Institute of Pathology of Circulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novosibirsk State Research Institute of Circulation Pathology
City
Novosibirsk
State/Province
Novosibirsk territory
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander V Bogachev-Prokophiev, PhD
Phone
+79137539546
Email
bogachev.prokophiev@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael S Fomenko
Phone
+79612183098
Email
enimol36@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael S Fomenko

12. IPD Sharing Statement

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Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

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