Respiration Rate V2.0 in a Hospital Setting

NCT01837537 | Completed Results

• 1 other identifier: COVMOPR0399
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 hospitalized volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR)(CO2).

Conditions

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor

  The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).

  up to 40 minutes of continuous monitoring

Secondary Outcomes (1)

• Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor

  up to 40 minutes of continuous monitoring

Study Arms (1)

no treatment

no treatment, prospective observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteer subjects from a hospital setting on the general care floor or general surgical care floor

You may qualify if:

• Male or female.
• years or older.
• A patient at the study site on a General Care Floor or General Surgery Care Floor.
• Subject is willing and able to provide written consent.

You may not qualify if:

• Subject is younger than 18.
• 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.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Results Point of Contact

• Title: Michael Luna-Victoria
• Organization: Medtronic

michael.luna-victoria@medtronic.com

303 305 2463

Study Officials

• Joshua Lumbley, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 23, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 17, 2017
• Results First Posted: February 3, 2017

Record last verified: 2017-06

Locations

US (1)