Pulse Oximetry- Evaluating Resp Rate- PCBA-1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Covidien

Boulder, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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COVMOPR0304

Identifier Type: -

Identifier Source: org_study_id