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

NCT04548687 | Unknown DMC

• 1 other identifier: 496
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carbon Dioxide

Keywords

carbon dioxide; cardiac surgery; delirium; minimally invasive intervention; redo cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• deaeration time

  intraoperatively

• neurocognitive dysfunction

  7 days after surgery

Study Arms (2)

carbon dioxide insufflation

ACTIVE COMPARATOR

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

Procedure: carbon dioxide insufflation

no carbon dioxide

OTHER

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

Procedure: No carbon dioxide insufflation

Interventions

carbon dioxide insufflation PROCEDURE

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

Also known as: carbon dioxide

carbon dioxide insufflation

No carbon dioxide insufflation PROCEDURE

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

Also known as: standard methods of deaeration

no carbon dioxide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation

Novosibirsk, Russia

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Carbon Dioxide

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Alexander V. Bogachev-Prokophiev, MD, PhD

  E.Meshalkin National medical research center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander V. Bogachev-Prokophiev, MD, PhD

CONTACT

+73833476029; bogachev.prokophiev@gmail.com

Sergei A. Budagaev

CONTACT

+73833476029; ser.bud.med@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Group 1: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities. Group 2: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 14, 2020
• Study Start: June 19, 2020
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2022
• Last Updated: September 14, 2020

Record last verified: 2020-06

Locations

RU (1)