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Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

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ClinicalTrials.gov Identifier: NCT02340741
Recruitment Status : Unknown
Verified March 2016 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : January 19, 2015
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Air Embolism Neurological Damage Procedure: conventional prophylaxis of aeroembolism Procedure: conventional prophylaxis plus CO2 insufflation Procedure: cardiac surgery with opening of heart chambers Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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

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: conventional prophylaxis plus CO2 insufflation
167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide

Procedure: cardiac surgery with opening of heart chambers
Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. hospital mortality [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02340741


Locations
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Russian Federation
Novosibirsk State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Novosibirsk territory, Russian Federation, 630055
Contact: Alexander V Bogachev-Prokophiev, PhD    +79137539546    bogachev.prokophiev@gmail.com   
Contact: Michael S Fomenko    +79612183098    enimol36@gmail.com   
Sub-Investigator: Michael S Fomenko         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Principal Investigator: Aleksandr V Bogachev-Prokophiev, PhD Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02340741     History of Changes
Other Study ID Numbers: 11-54-22
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
carbon dioxide
postoperative cerebrovascular complications
air embolism

Additional relevant MeSH terms:
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Embolism
Embolism, Air
Trauma, Nervous System
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Wounds and Injuries