Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

Air Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02340741
• Other study ID #: 11-54-22
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2014
• Last updated: July 5, 2015
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: July 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Air Embolism
• Embolism
• Embolism, Air
• Neurological Damage
• Trauma, Nervous System

Intervention

Procedure:
• conventional prophylaxis of aeroembolism
167 patients will be enrolled. Will perform standard way of aeroembolism prevention
• conventional prophylaxis plus CO2 insufflation
167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide
• cardiac surgery with opening of heart chambers
Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk	Novosibirsk territory

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 days	No
Secondary	hospital mortality		14 days	No