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临床试验/NCT04087070
NCT04087070Unknown不适用

Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Systolic and diastolic Blood pressure

研究概览

简要总结

The aim of this study is to estimate blood pressure in pediatric patients using a non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest.

详细描述

Blood pressure is measured by an automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands).

Following parameters will be measured by non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest and will be used to estimate the biosignal derived blood pressure.

  1. PAT(time between R peak of ECG and beginning of the pulse of PPG)
  2. PEP(time between R peak of ECG and peak of accelerometer signal)
  3. PTT(PAT-PEP)

The algorithm of the biosignal derived blood pressure will be made using the MATLAB 2016b(Mathworks, Natick, MA) program.

The agreement between the non-invasive blood pressure and the biosignal derived blood pressure will be analyzed using Cohen's Kappa or Bland-Altman plot.

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
— 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA(American Society of Anesthesiologist) Class I, II
  • Scheduled for elective surgery under general anesthesia

排除标准

  • History of cardiovascular disease
  • History of thoracic cavity disease
  • Unable to measure blood pressure

结局指标

主要结局

Systolic and diastolic Blood pressure

时间窗: During general anesthesia, up to 12 hours

Systolic and diastolic blood pressure by automated oscillometric device or arterial waveform from IntelliVue MX800 Bedside patient monitor (Philips Healthcare, Amsterdam, Netherlands).

次要结局

  • photoplethysmograph wave(During general anesthesia, up to 12 hours)
  • Electrocardiogram wave(During general anesthesia, up to 12 hours)
  • accelerometer signal(During general anesthesia, up to 12 hours)

研究者

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

Hee-Soo Kim

Professor

Seoul National University Hospital

研究点 (1)

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