Cerebral Oxygenation and Awareness During VT Ablation

NCT05097170 | Completed

• 1 other identifier: GO-21/704
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Oxygenation

Keywords

cerebral oxygenation; ventricular tachycardia ablation

Outcome Measures

Primary Outcomes (1)

• Near Infrared Spectrometer

  cerebral oxygenation

  perioperative (ventricular tachycardia ablation)

Secondary Outcomes (1)

• Bispectral Index

  perioperative (ventricular tachycardia ablation)

Study Arms (2)

1

patients under the age of 65

Procedure: NIRS during ventricular tachycardia ablation

2

patients above the age of 65

Procedure: NIRS during ventricular tachycardia ablation

Interventions

NIRS during ventricular tachycardia ablation PROCEDURE

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.

Also known as: BIS during ventricular tachycardia ablation

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing VT ablation procedure

You may qualify if:

• Patients over the age of 18
• Patients who will undergo VT ablation
• Patients who want to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Filiz Uzumcugil

Ankara, 06100, Turkey (Türkiye)

Location

Related 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.

  PMID: 30995375 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: November 1, 2021
• Primary Completion: February 23, 2022
• Study Completion: March 1, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)