跳至主要内容
临床试验/NCT05513482
NCT05513482招募中不适用

Prospective Evaluation of Diaphragm Kinetics With Tissue Doppler Imaging in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for AF ablation with a cryoballoon
  • ≥18 years old
  • Patients with interpretable diaphragm ultrasound before the operation
  • Patients giving informed consent

排除标准

  • Patients who did not give consent
  • Patients with phrenic nerve palsy
  • Morbid obesity

结局指标

主要结局

Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure

时间窗: 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.

次要结局

  • The effect of subclinical diaphragm damage on morbidity(Preoperative baseline and postoperative 24 hours)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Deniz Mutlu

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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