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临床试验/NCT03307889
NCT03307889已完成不适用

SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.

Uppsala University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.

研究概览

简要总结

Observational study in which pulse transit time (PTT) as a method and the device to register this data is compared with arterial blood pressure.

The population is composed of pediatric and adult patients in anesthesia or intensive care in need of arterial blood pressure monitoring.

详细描述

Plan to enroll patients who accept the terms of the study consecutively. The population is composed by pediatric and adult patients in anesthesia and intensive care in need of close blood pressure monitoring.

After informed consent from the patients themselves, patient and parents and sometimes only parents.

The device measuring PTT is the prepared and calibrated with existing arterial blood pressure. Data is then recorded via the storage capacity of the device and via videocamera. The videocamera is used to identify large disturbances in data registration. This is to identify confounding data and in the end calibrate the device to be more accurate.

Data from the PTT device and the camera is then downloaded to the study computer and to an external hard drive in order to create redundancy in data storage.

Data is then analysed to compare the difference between data recorded from the PTT device and arterial pressure respectively. Aim is to be able to collect sufficient data to be able to decide wether to recommend or advice against clinical use.

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

  • Arterial line planned or existing

排除标准

  • suspected major perioperative hemodynamic variation.
  • non existing consent.

结局指标

主要结局

Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.

时间窗: 45 minutes- 120 minutes

Difference in mmHg between blood pressure calculated by PTT and arterial blood pressure. A video will record the measurement session in order to determine any action correlating to changes in blood pressure. A second use of the video is to determine what other action taken around the patient causing noise or confounding measurements,

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Hultström

Associate professor

Uppsala University

研究点 (1)

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