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

NCT ID: NCT02048436

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-09-30

Brief Summary

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

Detailed 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.

Conditions

Respiratory Rate Accuracy Test

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

male female 18-45 years range of body types

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinimark, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinimark Laboratory

Louisville, Colorado, United States

Countries

United States

Other Identifiers

78o944o

Identifier Type: -

Identifier Source: org_study_id