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Respiration Rate V2.0 in a Hospital Setting

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ClinicalTrials.gov Identifier: NCT01837537
Recruitment Status : Completed
First Posted : April 23, 2013
Results First Posted : February 3, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Description
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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).

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Respiration Rate Parameters in a Hospital Population Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013
Groups and Cohorts
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Group/Cohort
no treatment
no treatment, prospective observational


Outcome Measures
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Primary Outcome Measures :
  1. Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor [ Time Frame: up to 40 minutes of continuous monitoring ]
    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).


Secondary Outcome Measures :
  1. Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor [ Time Frame: up to 40 minutes of continuous monitoring ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Volunteer subjects from a hospital setting on the general care floor or general surgical care floor
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837537


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Joshua Lumbley, MD The Ohio State University Wexner Medical Center
More Information
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01837537    
Other Study ID Numbers: COVMOPR0399
First Posted: April 23, 2013    Key Record Dates
Results First Posted: February 3, 2017
Last Update Posted: July 17, 2017
Last Verified: June 2017