Clinical Trials Directory

Trials / Completed

CompletedNCT01622842

Bioimpedance and Arterial Distension

Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension

Status
Completed
Phase
Study type
Observational
Enrollment
16 (actual)
Sponsor
Sense A/S · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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. 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.

Conditions

Timeline

Start date
2011-09-01
Primary completion
2011-09-01
Completion
2011-12-01
First posted
2012-06-19
Last updated
2012-06-22

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01622842. Inclusion in this directory is not an endorsement.