Pulse Oximetry- Evaluating Resp Rate- P… | Clinical Trial

Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Covidien

Boulder, Colorado, 80301, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Male or female subjects ages 18 or older.
Subject is willing and able to provide written consent.

Exclusion criteria

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.
Subjects with abnormalities that may prevent proper application of the device.
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 within thirty seconds).
Women who are pregnant or lactating.

Treatment and study plan

Primary outcomes

ME (mean error) of Respiration Rate values for each subject

Time frame: 1-2 hours per subject

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Feb 15, 2013
Registry last updated: Dec 6, 2013

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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Completed