Cerebral Oxygenation and Awareness During VT Ablation

NCT ID: NCT05097170

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patients under the age of 65

NIRS during ventricular tachycardia ablation

Intervention Type 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.

2

patients above the age of 65

NIRS during ventricular tachycardia ablation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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BIS during ventricular tachycardia ablation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Filiz Uzumcugil

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Filiz Uzumcugil

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30995375 (View on PubMed)

Other Identifiers

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GO-21/704

Identifier Type: -

Identifier Source: org_study_id

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