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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04548687
Other study ID # 496
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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