Bioimpedance and Arterial Distension

NCT ID: NCT01622842

Last Updated: 2012-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Hypertension

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Bioimpedance

8 females and 8 males BMI from 19 to 46 SBP from 119 to 182

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Sense A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Lading, Prof.

Role: STUDY_DIRECTOR

Sense A/S

Tine W Hansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet (Copenhagen Univ. Hospital)

Locations

Rigshopsitalet (Copenhagen Univ. Hospital)

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-1-2011-076

Identifier Type: -

Identifier Source: org_study_id