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Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02075398
Enrollment
35
Registered
2014-03-03
Start date
2013-12-31
Completion date
2013-12-31
Last updated
2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monitoring Arterial Oxygen Saturation

Keywords

Portable pulse oximeter

Brief summary

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

Interventions

None listed

Sponsors

Medtronic - MITG
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

* 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).

Design outcomes

Primary

MeasureTime frame
To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.up to 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026