Clinical trial NCT01622842: Bioimpedance and Arterial Distension
Official title: Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Impedance
Electrical
Tissue
Excitation frequency
arterial distension
distension wave form
Lead sponsor: Sense A/S
Sponsor class: INDUSTRY
Collaborators: name: Rigshospitalet, Denmark
First posted: 2012-06-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Equal number of females and males. Large variations of BMI Large variations of BP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz.
timeFrame: 1 hour
Secondary outcomes:
measure: Temporal variations synchronous with the heartbeat
timeFrame: 1 hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshopsitalet (Copenhagen Univ. Hospital)
Study officials:
affiliation: Sense A/S
name: Lars Lading, Prof.
role: STUDY_DIRECTOR
affiliation: Rigshospitalet (Copenhagen Univ. Hospital)
name: Tine W Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: