Clinical trial NCT02340741: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Air Embolism
Neurological Damage
Keywords: carbon dioxide
postoperative cerebrovascular complications
air embolism
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-01-19
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination
timeFrame: 14 days
Secondary outcomes:
measure: hospital mortality
timeFrame: 14 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Research Institute of Circulation Pathology
state: Novosibirsk territory
Study officials:
affiliation: Meshalkin Research Institute of Pathology of Circulation
name: Aleksandr V Bogachev-Prokophiev, PhD
role: PRINCIPAL_INVESTIGATOR
References: