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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Rate Accuracy Test

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

healthy Male or female, ages 18-45

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Respiratory Rate of test subject as compared to end tidal CO2	1 week

Collaborators and Investigators

• Sponsor: Clinimark, LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Respiratory Rate
• Other Study ID Numbers: 78o944o