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Bioimpedance and Arterial Distension

Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01622842
Acronym
SenseC1
Enrollment
16
Registered
2012-06-19
Start date
2011-09-30
Completion date
2011-12-31
Last updated
2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Impedance, Electrical, Tissue, Excitation frequency, arterial distension, distension wave form

Brief 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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Sense A/S
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

MeasureTime frameDescription
Temporal variations synchronous with the heartbeat1 hourThe 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026