Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2

Clinimark

Status: Completed

Conditions: Respiratory Rate Accuracy Test

Study type: Observational

Funder types: Other

Identifiers

NCT02048436

78o944o

Details and patient eligibility

About

The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system Respiration Rate technology.

Full description

After IRB Approval, eighteen volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate technology of the Perminova N4 Monitoring system (Device Under Test). The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.

A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35 and 40 breaths per minute; with some natural variation from these exact numbers.

Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study. Performance of the currently released ECG Impedance Respiratory Rate monitor (Acceptance Standard) will be used to establish the acceptance criteria in this study by comparing to Reference.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male
• female
• 18-45
• range of physiques
• healthy

Exclusion criteria

• injury to sensor area
• skin inflammation
• implanted devices such as pacemakers
• pregnant

Trial design

20 participants in 1 patient group

male female 18-45 years range of body types

Description:

18 male female subject mix that are 18-45 years of age and selected to represent a range of body types of varying physiques and body mass indexes