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临床试验/NCT01815034
NCT01815034已完成不适用

Transcutaneous Monitoring to Avoid Hypercapnea During Complex Catheter Ablations: a Joint Quality Initiative Pilot From Cardiac Electrophysiology and Anesthesiology

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Agreement with invasively obtained PCO2 data within 5 mm Hg

研究概览

简要总结

Use of trancutaneous CO2 (TC02) monitoring to aide in titration of sedation of midazolam and fentanyl. Trancutaneous readings validated with invasively obtained specimens from existing arterial sheaths required during AF and VT ablations (trans-septal and retrograde aortic respectively)

详细描述

Cardiac electrophysiology procedures are typically performed under moderate (conscious) sedation in most centers. Advantages over general anesthesia include facilitating arrhythmia induction, avoidance of intubation and ventilator related complications and shorter post-procedure recovery times for most patients. However, the cumulative respiratory depressant effects of fentanyl and midazolam during prolonged procedures can rarely cause hypoventilation resulting in hypercapnea and respiratory failure. Complex catheter ablations for atrial fibrillation and ventricular tachycardia can exceed 3-5 hours in duration requiring large cumulative doses of midazolam and fentanyl. End tidal CO2 monitors, particularly in non-ventilated patients, have limitations and obtaining frequent arterial blood gas samples are often impractical. It remains unknown if contemporary trancutaneous CO2 monitoring (TCO2)can provide a feasible alternative to avoid over-sedation and resultant respiratory complications during complex catheter ablations with sufficient agreement to invasively obtained PCO2 data.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing catheter ablation for atrial fibrillation (AF) or ventricular tachycardia (VT) under moderate sedation.

排除标准

  • Procedures scheduled for general anesthesia

结局指标

主要结局

Agreement with invasively obtained PCO2 data within 5 mm Hg

时间窗: up to 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Cantillon

Principal Investigator

The Cleveland Clinic

研究点 (1)

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