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临床试验/NCT01622842
NCT01622842已完成不适用

Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension

Sense A/S1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz.

研究概览

简要总结

The overall objectives were to investigate if characteristic dimensions for tissue and vessels determined from measured bioimpedance spectra would provide the same values as dimensions determined from MR images of the upper arm and verify that temporal variations of impedances could be converted to blood pressure.

详细描述

It is emphasized that measurements of pulse wave velocity was not a part of this trial, which implies that only uncalibrated blood pressures could be measured. The specific objectives were:

  1. To determine conductivities and permittivities in the spectral region from 1 KHz to 1 MHz for persons with: (a) a normal distribution of fat and muscles, (b) exceptionally thick layers of subcutaneous fat, and (c) exceptionally thin layers of subcutaneous fat. Both sexes should be represented.
  2. To verify that temporal variations synchronous with the heartbeat could be measured on all three groups.

Hypotheses:

A. That experimentally in vivo determined electrical parameters for tissues would differ considerably from theoretical values and from values measured in vitro experiments.

B. That the variations of the electrical parameters would exhibit little variation from person to person.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 80 years
  • Mental ability to understand information to test subjects

排除标准

  • Serious illness
  • Allergic reactions to ECG or EMG electrodes
  • Mentally unstable or unable to perceive instructions
  • Metal implants
  • Claustrophobia
  • Disqualified for MR scanning

结局指标

主要结局

Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz.

时间窗: 1 hour

Measured on persons with: (a) a normal distribution of fat and muscles, (b) exceptionally thick layers of subcutaneous fat, and (c) exceptionally thin layers of subcutaneous fat. Both sexes should be represented. Muscles and vessels followed expectations based on litterature values for electrical properties. Subcutaneous fat had a higher conductivity and permittivity than predicted from literature values in all cases.

次要结局

  • Temporal variations synchronous with the heartbeat(1 hour)

研究者

发起方
Sense A/S
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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