Bioimpedance and Arterial Distension

Hypertension Clinical Trial

— SenseC1  

Official title:

Bioimpedance of Human Tissue of the Upper Arm and Arterial Distension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622842
• Other study ID #: H-1-2011-076
• Status: Completed
• Phase: N/A
• First received: June 8, 2012
• Last updated: June 21, 2012
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Sense A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Denmark	Rigshopsitalet (Copenhagen Univ. Hospital)	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Sense A/S	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conductivities and permittivities in the spectral region from 1 KHz to 1 MHz.	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.	1 hour	No
Secondary	Temporal variations synchronous with the heartbeat	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.	1 hour	No