USDOE Human Subjects Research Database, fiscal year 1995

Sandia National Laboratories

Project Identifier: SNL-94-01

Project Title:

Personal Status Monitor (formerly Vital Sign Monitor for Ambulatory Patients)

Principle Investigator: Mr. Jerry Love

Project started in: 1994

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

No human subjects were involved in FY 1995 because the device was under development and not ready for testing on patients.

Funding Sources:

DOE: SNL LDRD

Amount: $359,000

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: April 26, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 50
(Reporting periods vary.)

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Objective: To develop and understand the sensor/human interface of a Personal Status Monitor (PSM) for ambulatory patients that will record blood pressure, heart rate, respiration, and core body temperature for routine patient monitoring in hospitals, for outpatients, and for home care.

Methodology: Vital signs will be measured at the superficial middle temporal portion of the external carotid artery in front of the ear, or on an orbital anterior auricular branch of this artery. This artery is readily compressed because it lies on bone. Compression of the artery to determine blood pressure requires a headband type platform to provide an opposing force, or an ear canal platform where a squeezing force can be applied. Either platform permits the mounting of sensors for measuring other parameters, i.e., core body temperature, which can be measured in the ear canal. Other suitable sensor sites included in the study are wrist and finger. No electrical contact with tissue is required. The desired vital signs can be determined with an infrared (IR) and red sensor, a pressure transducer, and a temperature transducer. Non-occlusive techniques to indirectly determine blood pressure will also be explored.

Involvement of Human Subjects: Subjects will be used to obtain measurement and calibration data for the development of this project--only the basic concept has been developed. No known risk is involved with human subjects. All techniques use conventional measurement and control techniques, e.g., compression of an artery to determine blood pressure.