Respiration Rate V2.0 in a Hospital Setting

Evaluation of Respiration Rate Parameters in a Hospital Population 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 hospitalized 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: Respiratory Rate

Detailed Description

Volunteer subjects from a hospital setting (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. A cross section of demographics - cardiovascular, respiratory, and metabolic type cases should be considered for a broad distribution of medical and surgical patients.

The study consists of measuring parameters related to respiration in hospitalized volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The production-equivalent 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): 90

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Male or female.
• 18 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.

Exclusion Criteria:

• 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.

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor	The software calculates respiration rate values via the Max-N 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). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.	up to 40 minutes of continuous monitoring

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: COVMOPR0399