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

Carbon Dioxide Clinical Trial

— CAR-DRIVER  

Official title:

Pilot Prospective Randomized Clinical Trial "Insufflation of Carbon Dioxide During Minimally Invasive and Repeated Cardiac Surgery"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04548687
• Other study ID #: 496
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: June 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander V. Bogachev-Prokophiev, MD, PhD
• Phone: +73833476029
• Email: bogachev.prokophiev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carbon Dioxide

Intervention

Procedure:
• carbon dioxide insufflation
Carbon dioxide insufflation at a rate of 5 l / min. through the Redon drainage during cardiac surgery (minimally invasive or repeated) during cardiopulmonary bypass
• 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

Locations

Country	Name	City	State
Russian Federation	"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation	Novosibirsk

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	delirium: CAM-ICU, 3-D CAM	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.	7 days after surgery
Secondary	deaeration time	deaeration time according to transesophageal echocardiography data	intraoperatively
Secondary	neurocognitive dysfunction	development of neurocognitive dysfunction: Montreal Cognitive Assessment - two days before surgery and 7 days after surgery	7 days after surgery