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Completed

NCT Number: NCT01804062

Respiration Rate V2.0 in Healthy Volunteers

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boulder In-House Clinical Laboratory

Boulder, Colorado, 80301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2013
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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