Ultrasonography Evaluation of Diaphragm Kinetics in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05513482
Collaborator
(none)
80
16.1

Study Details

Study Description

Brief Summary

The purpose of this study to assess the diaphragm kinetics with Tissue Doppler Imaging in patients undergoing atrial fibrillation ablation with cryoballoon

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Tissue Doppler Imaging
  • Diagnostic Test: M Mode Imaging

Detailed Description

This study is designed to evaluate the diaphragm kinetics with ultrasonography parameters in patients who underwent pulmonary vein isolation (PVI) for atrial fibrillation (AF) by Cryoballoon. Due to the proximity of the pulmonary veins to the phrenic nerve, phrenic nerve paralysis can be seen rarely during the procedure. In contemporary practice, phrenic nerve damage is detected by visual monitoring of diaphragm movement as a result of pacing with high output by placing the intracardiac stimulation catheter at the level of the superior vena cava. However, subclinical nerve damage may be critical regarding respiratory functions, especially in patients with comorbidities. It has been shown in the literature that the evaluation of diaphragm kinetics with Tissue Doppler Imaging (TDI) can be used in effective ventilation monitoring and weaning. However, this technique has not been used in patients who have previously undergone cryoballoon therapy. It is aimed to investigate the positive or negative effects on diaphragm kinetics, as a very cost-effective and rapidly accessible technique, with the help of this technique.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Diaphragm Kinetics With Tissue Doppler Imaging in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Cryoballoon pulmonary vein isolation for atrial fibrillation ablation

Diaphragmatic kinetics of participants before and after pulmonary vein isolation will be evaluated with the Tissue Doppler and M Mode Imaging.

Diagnostic Test: Tissue Doppler Imaging
With tissue Doppler ultrasonography (TDI), the maximum contraction rate of the diaphragm, maximum relaxation rate, and integral against time will be examined.
Other Names:
  • GE Vivid T8 Ultrasonography System
  • Diagnostic Test: M Mode Imaging
    Diaphragm displacement during inspiration and expiration will be measured with M mode imaging
    Other Names:
  • GE Vivid T8 Ultrasonography System
  • Outcome Measures

    Primary Outcome Measures

    1. Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure [Preoperative baseline and postoperative first hour]

      Unlike the traditional method, diaphragm Tissue Doppler imaging (TDI) will be used to diagnose phrenic nerve injury in patients during cryoballoon ablation. This method aims to detect the damages that may have occurred even though no visible damage has occurred. The peak contraction velocity (PCV) that has been found to be effective on weaning success will be used in TDI. The literature shows that the PCV measured by TDI in healthy humans is 1.32 ⨦ 0.39 cm/sec. Based on this, the patient's baseline and post-procedure PCVs will be compared.

    Secondary Outcome Measures

    1. The effect of subclinical diaphragm damage on morbidity [Preoperative baseline and postoperative 24 hours]

      Side effects that may occur as a consequence of these will be observed in patients with subclinical diaphragm injury.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients scheduled for AF ablation with a cryoballoon

    • ≥18 years old

    • Patients with interpretable diaphragm ultrasound before the operation

    • Patients giving informed consent

    Exclusion Criteria:
    • Patients who did not give consent

    • Patients with phrenic nerve palsy

    • Morbid obesity

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Istanbul University-Cerrahpasa

    Investigators

    • Study Chair: Kivanc Yalin, Assoc Prof., Istanbul University-Cerrahpasa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deniz Mutlu, Principal Investigator, Istanbul University-Cerrahpasa
    ClinicalTrials.gov Identifier:
    NCT05513482
    Other Study ID Numbers:
    • 2022/449352
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Deniz Mutlu, Principal Investigator, Istanbul University-Cerrahpasa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022