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临床试验/NCT06117111
NCT06117111已完成不适用

The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Electrocardiography (ECG)

研究概览

简要总结

This clinical investigation assesses the performance of PaMo patient monitor system (PaMo) and its wearable sensing devices that combines continuous IP, ECG and PPG in detecting developing respiratory depression episodes. PaMo patient monitor system consists of a wearable measurement unit worn on a patient, bedside mobile unit that receives the data from the wearable unit through Bluetooth Low Energy connection, visualises it, and can be relayed further to the central unit through WiFi network.

详细描述

Monitoring of voluntary subjects undergoing major surgery requiring postoperative intensive care treatment with PaMo patient monitoring device that includes continuous ECG, respiration and PPG monitoring.

The monitoring device is connected during anaesthesia preparation before induction of general anaesthesia and monitoring is continued throughout the surgery and in the intensive care unit (ICU) for total of 24 hours. For reference data, GE Carescape B850 patient monitors are used continuously for oxygen saturation, ECG and respiration signals. The data are collected from the reference patient monitor using a S/5 collect software and a study computer. In addition, to obtain a gold standard reference for SpO2 with blood gas analyzer arterial samples are taken every two hours during anesthesia and in the ICU concurrently with the routine checkups. During the surgery, an arterial cannula collects continuous blood pressure data and can be used for taking blood samples. The data collected with PaMo device and reference monitor are analyzed in Tampere University by researchers and used in device, software and algorithm development.

User experience information and usability feedback are collected at the end of the study from the medical staff with an interview form.

The study does not include a control group. All subjects are using the devices in similar way and the parameters collected from the same individual using two different methods are compared.

研究设计

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

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

  • Age: minimum of 18 years
  • Undergoing pancreatic or ENT tumour surgery
  • Ability to give informed consent
  • Volunteering to the study

排除标准

  • Age under 18 years
  • Insufficient knowledge in Finnish
  • Cardiac pacemaker
  • Inability to give informed consent

结局指标

主要结局

Electrocardiography (ECG)

时间窗: Continuous measurement 24 hours

Mean error an mean absolute error between the study device and standard monitor heart rae

Plethysmography

时间窗: Continuous measurement 24 hours

Mean error and mean absolute error between the study monitor and standard monitor

Respiration rate

时间窗: Continuous measurement 24 hours

Mean error and mean absolute error between the study monitor and standard monitor

次要结局

  • usability(Continuous measurement 24 hours)
  • blood pressure(Continuous measurement 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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