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Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02340741
Enrollment
334
Registered
2015-01-19
Start date
2014-09-30
Completion date
2017-09-30
Last updated
2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air Embolism, Neurological Damage

Keywords

carbon dioxide, postoperative cerebrovascular complications, air embolism

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).

Interventions

PROCEDUREconventional prophylaxis of aeroembolism

167 patients will be enrolled. Will perform standard way of aeroembolism prevention

PROCEDUREconventional prophylaxis plus CO2 insufflation

167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide

PROCEDUREcardiac surgery with opening of heart chambers

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

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination14 daysconducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination

Secondary

MeasureTime frame
hospital mortality14 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026