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临床试验/NCT03697291
NCT03697291Unknown不适用

Comparison of the Self-invented Intracavitary ECG Wire With the Commercial System - Certodyn®

Mahidol University4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
36
试验地点
4
主要终点
Signal noise ratio

研究概览

简要总结

Peripherally Inserted Central Catheter (PICC) is considered a central venous line placement (CVL) which mandates the confirmation of the tip's location. At present, most CVL's position are confirmed by radiographic method either by in-procedure fluoroscopy or post-insertion x-ray. For CVLs placed from upper body (from internal jugular vein, subclavian veins or upper arm veins), the intracavitary electrocardiogram (iECG) can also be used.

Intracavitary ECG are proven effective for tip confirmation and provide some benefits i.e. lower cost, decrease exposure to harmful radiation for care providers and also the patients, require less personals and equipments, provide real-time confirmation as comparable to fluoroscopy, etc. There are several devices and makes of iECG apparatus but B.Braun-Certodyn® remains the only available system in our institution. The limitation is the availability of the Certodyn devices on each locations where CVL will be placed i.e. operating theater, intensive care unit, bedside placement, radiology suite, etc. Since the connecting wire is only supplied in the certain CVL kits under B.Braun brand, this has rendered iECG for other types or makes of CVL or PICC line become even more difficult.

Self-invented connector wire for iECG (PS wire) has been made and used effectively in the past few years at Siriraj hospital. The patent registration is underway and the author seek to compare this PS wire against the commercial Certodyn system.

详细描述

Objective

  1. To evaluate the success rate of iECG CVL tip confirmation by self-invented iECG connector wire.
  2. To compare quality of iECG tracing produced from both of self-invented iECG wire versus the Certodyn system.

Materials, participants and study method

Equipments required:

  1. Self-invented iECG wire (PS wire) 2) Commercial iECG system which consists of the Certodyn and the wire. 3) Standard ECG monitoring system which can display and printout the ECG tracing. 4) A digital ECG caliper which can measure P wave amplitude and noise segment in millimeter up to 2 decimal points. Study method

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

unlabeled ECG print

入排标准

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

入选标准

  • Patient age 18 years and above.
  • Requires PICC line insertion from upper torso.

排除标准

  • Children younger than 18 years.
  • Patient with atrial fibrillation or other rhythms not generated from intrinsic SA node i.e. pacer, atrial fibrillation, etc.
  • Unstable hemodynamic.
  • Patient with history arrhythmias.
  • Patient with HR > 120 bpm.
  • Patients with hypercoagulable state.
  • Allergy to heparin.
  • Patients with known heparin induced thrombocytopenia.
  • Patients with known Creutzfeldt-Jakob Disease.

研究组 & 干预措施

PS wire

Experimental

self-invented iECG wire

干预措施: PS wire (Device)

Certodyn

Active Comparator

Commercially available iECG system - Certodyn

干预措施: PS wire (Device)

结局指标

主要结局

Signal noise ratio

时间窗: 10 minutes

Measuring the segment of ECG noise (if exists) in millimeters compare to the total ECG segment. Compare this signal noise ratio between the baseline surface ECG, the self-invented wire derived iECG and the Certodyn derived iECG.

次要结局

  • The amplitude of giant P Wave(5 minutes)

研究者

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

Prasert Sawasdiwipachai

Principal investigator

Mahidol University

研究点 (4)

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