- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06538987
Anesthetic Management in Patients Undergoing Epicardial Ablation
Anesthetic Management in Patients Undergoing Epicardial Ablation for the Treatment of Ventricular Tachycardia; Retrospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is retrospective observational and data were collected by examining the files of all epicardial ablation patients received in the angiography unit starting from 30.10.2020 until 30.10.2022 after ethics committee approval is obtained. Baseline characteristic features of the patients Sex, Age, (years, BMI (kg/m2) Hypertension, Coronary artery disease, COPD (Chronic obstructive pulmonary disease), CKD (Chronic kidney disease) Electrical storm, and ventricular tachycardia etiology, Ischemic cardiomyopathy, Dilated cardiomyopathy, the presence of ARVC (Arrhythmogenic Right Ventricular Cardiomyopathy), Hypertrophic cardiomyopathy will be recorded. NHYA classification will be examined in two groups as NHYA I or II and NHYA III or IV, also estimated glomerular filtration rate, left ventricular ejection fraction, PAAINESD (acute hemodynamic decompensation risk assessment score), iVT score (Risk of VT recurrence) Score information will be recorded. Ventricular tachycardia focus locations, dopamine, dobutamine, norepinephrine infusion requirement during the procedure, arrest development during the procedure, fluoroscopy time and ablation times will be recorded. In the follow-up of the patients after the procedure Causes of death, decompensated heart failure, transient ischemic attack, development of acute renal failure, and recurrence of ventricular tachycardia will be recorded. PAAINESD score (acute hemodynamic decompensation risk assessment score) will be recorded. The PAAINESD Score, developed to estimate the risk of periprocedural hemodynamic decompensation, has values ranging from 0 to 35 points (or 0 to 31 [PAINESD] when the modifiable intraprocedural variable "general anesthesia" is excluded). duration of the procedure, the need for inotropes during the procedure, whether the patient needed mechanical ventilation after the procedure, and the success rates after the procedure will be recorded.
PAINESD Pulmonary disease (chronic obstructive pulmonary disease) 5 Age >60 years 3 Anaesthesia (general) 4 Ischaemic cardiomyopathy 6 NYHA class III or IV 6 Ejection fraction <25 % 3 Storm (VT). 5 Diabetes 3 Data will be analyzed in three separate categories, the characteristics of the patients before the procedure, during the procedure and after the procedure. Descriptive tables and percentages of parameters will be created by statistical analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Odunpazarı
-
Eski̇şehi̇r, Odunpazarı, Turkey, 26040
- University of Eskisehir Osmangazi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: • age > 18 years old who underwent elective VT ablation between 2020 - 2022,
- primary anesthetic type listed as general anesthesia
Exclusion Criteria: • age < 18 years,
- missing follow-up data,
- patients who have previously undergone epicardial ablation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight
Time Frame: 2 years
|
kilograms
|
2 years
|
|
sex
Time Frame: 2 years
|
male %
|
2 years
|
|
age
Time Frame: 2 years
|
years
|
2 years
|
|
height
Time Frame: 2 years
|
meters
|
2 years
|
|
Hypertension
Time Frame: 2 years
|
yes or no
|
2 years
|
|
Diabetes mellitus
Time Frame: 2 years
|
yes or no
|
2 years
|
|
Coronary artery disease
Time Frame: 2 years
|
yes or no
|
2 years
|
|
Chronic obstructive pulmonary disease
Time Frame: 2 years
|
yes or no
|
2 years
|
|
Chronic kidney disease
Time Frame: 2 years
|
yes or no
|
2 years
|
|
Systolic pulmonary artery pressure
Time Frame: 2 years
|
mmHg
|
2 years
|
|
PAAINESD (Acute hemodynamic decompensation risk assessment, ranging from 0 to 35 points, 35 point is the worst) score
Time Frame: 2 years
|
score 0-35
|
2 years
|
|
ASA ( American Society of Anesthesiologists (ASA) physical status classification ranging from I to IV
Time Frame: 2 years
|
score I-IV
|
2 years
|
|
Hemoglobin
Time Frame: 2 years
|
g/dl
|
2 years
|
|
glomerular filtration rate (eGFR)
Time Frame: 2 years
|
ml/dak/1,73m2
|
2 years
|
|
Total procedural time
Time Frame: 2 years
|
minutes
|
2 years
|
|
Fluoroscopy time
Time Frame: 2 years
|
minutes
|
2 years
|
|
Ablation time
Time Frame: 2 years
|
minutes
|
2 years
|
|
Left ventricular ejection
Time Frame: 2 years
|
%
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Transient ischemic attack after procedure
Time Frame: 2 years
|
yes or no
|
2 years
|
|
Exitus during the follow-up
Time Frame: 2 years
|
yes or no
|
2 years
|
|
cause of death
Time Frame: 2 years
|
End-Stage heart failure, VT storm
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ferda yaman, Assoc prof, University of Eskisehir Osmangazi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EskisehirU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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