Skip to main content
OpenTrials
Completed

NCT Number: NCT01622842

Bioimpedance and Arterial Distension

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshopsitalet (Copenhagen Univ. Hospital)

Copenhagen, DK-4011, Denmark

About this study

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:

  • 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.
  • 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.

C. Those simple experimental relations can be established for the electrical parameters by including a simple vascularization model.

D. That it is possible to measure temporal variation of the impedance, which are synchronous with the heartbeat.

E. That the measured values would facilitate the calculation of the differential blood pressure with accuracies better than 10 mmHg.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Temporal variations synchronous with the heartbeat

    Time frame: 1 hour

    The temporal variations of impedances 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. Temporal variations could be measured on all three groups.

Sponsors and collaborators

Lead sponsor

Sense A/S

Industry

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension

Acronym: SenseC1

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 19, 2012
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.