Respiration Rate V2.0 in Healthy Volunteers

Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).

Study Overview

• Status: Completed
• Conditions: Focus of the Study is Measuring Respiratory Rate

Detailed Description

Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors.

The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Boulder In-House Clinical Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Volunteer subjects with no significant medical problems

Description

Inclusion Criteria:

• Male or female subjects.
• 18 years or older.
• Subject is willing and able to provide written consent.

Exclusion Criteria:

• Subject is younger than 18.
• Subject is pregnant or lactating
• Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
• Subject has an abnormality that may prevent proper application of the device.
• Subject is in atrial fibrillation.
• Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds
• Subject has an implanted pacemaker.
• Subject is unwilling or unable to sign informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
no treatment; no treatment, prospective observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor	The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.	up to 40 minutes of continous monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ME +/- 1 Breath Per Minute, Max-N Sensor	The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.	up to 40 minutes of continuous monitoring

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Scott D Kelley, MD, Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (ESTIMATE): March 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 10, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: COVMOPR0394