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CompletedNCT02075398Updated Mar 3, 2014

Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

An observational study in Monitoring Arterial Oxygen Saturation, sponsored by Medtronic - MITG. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-03.

Sponsored by Medtronic - MITG (part of Medtronic) · Observational

Study type
Observational
Model
Case-only
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study summary

To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside Respiratory Patient Monitoring System, for performance during motion conditions.

02

Conditions studied

  • Monitoring Arterial Oxygen Saturation

Keywords

  • Portable pulse oximeter
03

In context

Lead sponsor

Medtronic - MITG is the lead sponsor of 178 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse Medtronic - MITG studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects will be recruited from the available Covidien Boulder Clinical Laboratory subject data base.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or Female subjects 18 years or older (inclusive)
  • Subject is able to participate for the duration of the study
  • Subject is willing to sign an informed consent

Exclusion criteria

Exclusion Criteria:

  • Subject with abnormalities that may prevent proper application of the devices
  • Physiologic abnormalities that prevent proper application of pulse oximetry sensor
  • Severe contact allergies that cause a reaction to standard adhesive materials such as those fund in medical sensors and electrodes
  • Subjects with significant arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse with thirty seconds).
05

Study design

Observational model
Case-only
Enrollment
35 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.

    Time frame: up to 3 months

07

Study locations

1 site
  • Boulder Clinical Laboratory
    Boulder, Colorado 80301, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2014
First posted
Mar 3, 2014
Start
Dec 2013
Primary completionActual
Dec 2013
CompletionActual
Dec 2013
Last update
Mar 3, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02075398
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Mar 3, 2014
Start date
Dec 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 3, 2014

Study contacts

Kelley Scott, MD
principal investigator · Medtronic - MITG

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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