Cerebral Oxygenation and Awareness During VT Ablation

Cerebral Oxygenation Clinical Trial

Official title:

Determining the Effect of Vital Parameters on Cerebral Oxygenation and Awareness During Ventricular Tachycardia Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097170
• Other study ID #: GO-21/704
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is aimed to examine the effect of the decrease in blood pressure that occurs during the ventricular tachycardia ablation process on cerebral oxygenation and awareness.

Patient's age, cardiac measurements (ejection fraction-EF), basal vital values, procedure time (especially activation and pacing mapping), and localization of the arrhythmia, may affect the NIRS and BIS response to blood pressure drop. In addition to the effects of patients' demographic information, cardiac capacity and procedure time on NIRS and BIS values (downtrend and duration), correlations of these values with other monitoring parameters (ETCO2 and SpO2) intended to be displayed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 1, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over the age of 18

• Patients who will undergo VT ablation

• Patients who want to participate in the study

Exclusion Criteria:

• Patients whose baseline values could not be obtained before induction

• Patients with severe neurological or psychiatric illness

• Patients who do not want to participate in the study

Related Conditions & MeSH terms

• Cerebral Oxygenation
• Tachycardia
• Tachycardia, Ventricular

Intervention

Procedure:
• NIRS during ventricular tachycardia ablation
NIRS: Near-infrared spectroscopy is a measurement technique that non-invasively and continuously monitors the balance between cerebral oxygen consumption and delivery. BIS: BIS is an electroencephalogram-derived parameter developed to monitor the hypnotic effects of anesthesia.

Locations

Country	Name	City	State
Turkey	Filiz Uzumcugil	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Shivkumar K. Catheter Ablation of Ventricular Arrhythmias. N Engl J Med. 2019 Apr 18;380(16):1555-1564. doi: 10.1056/NEJMra1615244. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near Infrared Spectrometer	cerebral oxygenation	perioperative (ventricular tachycardia ablation)
Secondary	Bispectral Index	awareness	perioperative (ventricular tachycardia ablation)