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临床试验/NCT03556241
NCT03556241Unknown不适用

Perioperative Management of Patients With Pacemakers

Yong Seog Oh1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Occurrence of asystole

研究概览

简要总结

Traditionally, when a patient who received permanent pacemaker undergoes surgery, physicians change pacemaker mode to DDD and recommend to use bipolar electrocautery to minimize electromagnetic interference. However, pacemaker function is improving and there's diverse suggestions for such situations. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in case group and VOO is applied before surgery in control group. Perioperative adverse event would be compared in both groups.

详细描述

It has been more than 50 years after pacemaker device is developed. The subjects receiving permanent pacemaker has been increased and the number of patients with pacemaker undergoing surgery has been increased in company. However, in cases using electrocautery during surgery, there is possibility of malfunction of pacemaker due to electromagnetic interference. The factors associated with pacemaker malfunction during surgery have been reported; type of pacemaker, intrinsic heart rate, pacemaker dependency, type of electrocautery, position of generator, distance between generator/lead and electrocautery, duration and power of electrical energy. Conventionally, mode change to VOO before surgery and use of bipolar electrocautery are recommended before surgery but diverse suggestions regarding perioperative pacemaker mode change has been raised. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change by prospective randomized trial. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in the case group and VOO mode is applied before surgery in the control group. Exclusion criteria is thoracic surgery, 100% pacemaker dependency and unipolar pacing. The investigators will compare perioperative adverse events. The primary endpoint is asystole and the secondary endpoint is cardiac arrest, pacing inhibition, torsades de pointes and R on T.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •over 19 years old Patients undergoing surgery using electrocautery who received permanent pacemaker

排除标准

  • •Thoracic surgery (lung, esophagus, heart, breast) Totally pacemaker dependent patient. Unipolar pacing

研究组 & 干预措施

Intervention: No change group

Experimental

Case management consists keeping patient's current pacemaker mode during surgery

干预措施: Case management (Device)

Control: Mode change group

No Intervention

Usual care consists changing pacemaker mode to VOO before surgery

结局指标

主要结局

Occurrence of asystole

时间窗: Perioperative period

次要结局

未报告次要终点

研究者

发起方
Yong Seog Oh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yong Seog Oh

professor

Seoul St. Mary's Hospital

研究点 (1)

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