Pulse Oximetry- Evaluating Resp Rate- PCBA-1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT01791582
• Lead Sponsor: Medtronic - MITG

Brief Summary

To assess performance of resp rate parameter in a monitoring system PCBA-1

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Subjects with abnormalities that may prevent proper application of the device.
3. 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).
4. Women who are pregnant or lactating.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ME (mean error) of Respiration Rate values for each subject	1-2 hours per subject

Trial Locations

Locations (1)

Covidien; 🇺🇸 Boulder, Colorado, United States