Respiration Rate V2.0 in Healthy Volunteers

NCT ID: NCT01804062

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-02-28

Brief Summary

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).

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.

Conditions

Focus of the Study is Measuring Respiratory Rate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

no treatment

no treatment, prospective observational

No interventions assigned to this group

Eligibility Criteria

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.

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

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott D Kelley, MD

Role: PRINCIPAL_INVESTIGATOR

Medtronic - MITG

Locations

Boulder In-House Clinical Laboratory

Boulder, Colorado, United States

Countries

United States

Other Identifiers

COVMOPR0394

Identifier Type: -

Identifier Source: org_study_id