a Randomized Clinical Trial Evaluating the Effectiveness of Carbon Dioxide Use in Cardiac Surgery

Not Applicable

• Conditions: Carbon Dioxide
• Interventions: Procedure: carbon dioxide insufflation; Procedure: No carbon dioxide insufflation

• Registration Number: NCT04548687
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive

Detailed Description

prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-19
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-08
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14
• Primary Completion: 2021-06-20
• Study Completion: 2022-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Planned cardiac surgery on the left heart with limited deaeration: Minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); Re-intervention
• Signed informed voluntary consent

Exclusion Criteria

• Patient refusal to participate in any stage of the study
• History of stroke, transient ischemic attack
• Hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%)
• Swelling or thrombosis of the heart
• LV dysfunction (EF less than 30%)
• Atherosclerosis of the aorta (atheromatosis)
• Surgical access conversion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbon dioxide insufflation	carbon dioxide insufflation	patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery + standard methods of deaeration of cardiac cavities
no carbon dioxide	No carbon dioxide insufflation	standard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle

Primary Outcome Measures

Name	Time	Method
delirium: CAM-ICU, 3-D CAM	7 days after surgery	positive test development of postoperative delirium: Richmond Agitation-Sedation Scale, Confusion Assessment Method-Intensive Care Unit (more than one error) - while in the intensive care unit; positive test the 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM) defined delirium - while in the ward of the department: The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness.

Secondary Outcome Measures

Name	Time	Method
deaeration time	intraoperatively	deaeration time according to transesophageal echocardiography data
neurocognitive dysfunction	7 days after surgery	development of neurocognitive dysfunction: Montreal Cognitive Assessment - two days before surgery and 7 days after surgery

Trial Locations

Locations (1)

"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation; 🇷🇺 Novosibirsk, Russian Federation