跳至主要内容
临床试验/NCT06986577
NCT06986577进行中(未招募)不适用

Evaluation of Mechanical Ventilation Methods Applied During the Procedure in Pediatric Cardiac Radiofrequency Ablation Interventions: Prospective Observational Study

Izmir City Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Contact force

研究概览

简要总结

The aim of this study is to describe the results of cardiac radiofrequency ablation under general anesthesia.

to evaluate mechanical ventilation methods in pediatric patients. The main questions it aims to answer are

  1. Whether lower tidal volume high frequency mechanical ventilation effects the success of radiofrequency ablation in pediatric cardiac arryhtmia patient?
  2. The effect of mechanical ventilation strategies on the number of effective lesions, radiofrequency ablation time and arrhythmia recurrence in the first month

详细描述

Radiofrequency ablation (RF) is an effective method for the threatment of cardiac arrhythmias in pediatric patients. General anaesthesia and mechanical ventilation is the most common anesthesia management for pediatric arrhythmia patients. During the prosedure, thoracic excursion results in displacement of the catheter and disrupts the catheter stability which is crucial for quality of contact force (CF), sufficient ablation and safety. To minimize the thoracic excursion, high frequency low tidal volume ventilation and apnea ventilation may be needed during radiofrequency ablation. According to investigators knowledge there are studies about ventilatory strategies in adult patients who underwent cardiac radiofrequency ablation. However, there are no studies corcerning pediatric patients. In this study investigators aimed to investigate best ventilatory strategy for minimize thoracic excursion in pediatric patients with general anaesthesia. In this study investigators are going to observe 3 different ventilation strategies on radiofrequency ablation.

  1. Lung protective mechanical ventilation with 7-9 ml/kg tidal volume,
  2. Low tidal volume (4 ml/kg) high frequency mechanical ventilation
  3. Apnea ventilation during radiofrequency ablation

研究设计

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

入排标准

年龄范围
0 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between 0-18 years
  • Paediatric surgery under general anaesthesia at Izmir City Hospital in the last 3 months since the date undergoing cardiac radiofrequency ablation procedure
  • Procedures were performed with catheters with contract force measurement feature patients with

排除标准

  • Patients with maintenance other than inhalation anaesthesia
  • Patients whose anaesthesia method is changed during the procedure
  • Patients with airway complications
  • Development of haemodynamic instability during the procedure
  • Patient with a history of previous cardiac surgery
  • Presence of additional cardiac disease, advanced connective tissue disease, connective tissue disease, mitochondrial muscle disease

研究组 & 干预措施

2) Low tidal volume high frequency ventilation

Mechanical ventilation with 4 ml tidal volume with high frequency during RF

3) Apnea ventilation

Apne ventilastion during RF

1) Lung protective mechanical ventilation

Mechanical ventilation with 7-9 ml tidal volume during RF

结局指标

主要结局

Contact force

时间窗: intraprosedural

continuously measured through the catheter

次要结局

  • Lession count(intraprosedural)
  • Time(intraprosedural)

研究者

发起方
Izmir City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gözde Gürsoy Çirkinoğlu

MD

Izmir City Hospital

研究点 (1)

Loading locations...

相似试验