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Respiration Rate V2.0 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01804062
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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).

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Study Start Date : February 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Group/Cohort
no treatment
no treatment, prospective observational



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


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



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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteer subjects with no significant medical problems
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.

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): NCT01804062


Locations
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United States, Colorado
Boulder In-House Clinical Laboratory
Boulder, Colorado, United States, 80301
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Scott D Kelley, MD Medtronic - MITG

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01804062     History of Changes
Other Study ID Numbers: COVMOPR0394
First Posted: March 5, 2013    Key Record Dates
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015
Last Verified: July 2015