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Respiration Rate V2.0 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 20, 2013
First Posted Date March 5, 2013
Results First Submitted Date July 14, 2015
Results First Posted Date August 10, 2015
Last Update Posted Date August 10, 2015
Study Start Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2013)
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.
Original Primary Outcome Measures
 (submitted: March 1, 2013)
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.
Change History Complete list of historical versions of study NCT01804062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 1, 2013)
4-40 bpm operating range [ Time Frame: up to 40 minutes of continuous monitoring ]
The software shall provide respiration rate across an operating range of 4 to 40 breaths per minute.
 
Descriptive Information
Brief Title Respiration Rate V2.0 in Healthy Volunteers
Official Title Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Volunteer subjects with no significant medical problems
Condition Focus of the Study is Measuring Respiratory Rate
Intervention Not Provided
Study Groups/Cohorts no treatment
no treatment, prospective observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2013)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01804062
Other Study ID Numbers COVMOPR0394
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic - MITG
Study Sponsor Medtronic - MITG
Collaborators Not Provided
Investigators
Principal Investigator: Scott D Kelley, MD Medtronic - MITG
PRS Account Medtronic - MITG
Verification Date July 2015