Cerebral Oxygenation and Awareness During VT Ablation

Sponsor

Hacettepe University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05097170

Collaborator

(none)

Enrollment

Location

3.9

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Oxygenation	Procedure: NIRS during ventricular tachycardia ablation

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Feb 23, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
1 patients under the age of 65	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. Other Names: BIS during ventricular tachycardia ablation
2 patients above the age of 65	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. Other Names: BIS during ventricular tachycardia ablation

Arm

Intervention/Treatment

patients under the age of 65

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.

Other Names:

BIS during ventricular tachycardia ablation

patients above the age of 65

Procedure: NIRS during ventricular tachycardia ablation

Other Names:

BIS during ventricular tachycardia ablation

Outcome Measures

Primary Outcome Measures

Near Infrared Spectrometer [perioperative (ventricular tachycardia ablation)]
cerebral oxygenation

Secondary Outcome Measures

Bispectral Index [perioperative (ventricular tachycardia ablation)]
awareness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Filiz Uzumcugil	Ankara		Turkey	06100

Sponsors and Collaborators

Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Shivkumar K. Catheter Ablation of Ventricular Arrhythmias. N Engl J Med. 2019 Apr 18;380(16):1555-1564. doi: 10.1056/NEJMra1615244. Review.

Responsible Party:

Filiz Uzumcugil, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT05097170

Other Study ID Numbers:

GO-21/704

First Posted:

Oct 28, 2021

Last Update Posted:

Mar 10, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Filiz Uzumcugil, Principal Investigator, Hacettepe University

cerebral oxygenation

ventricular tachycardia ablation

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Ventricular

Study Results

No Results Posted as of Mar 10, 2022