Pulse Oximetry- Evaluating Sensor Off- PCBA-1

NCT ID: NCT01791569

Last Updated: 2013-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-09-30

Brief Summary

To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications when the sensor is removed from the finger.

Conditions

Healthy Subjects

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects 18 or older (inclusive).

2. Subject is able to participate for the duration of the study

3. Subject is willing to sign an informed consent

Exclusion Criteria

1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors

2. Physiologic abnormalities that prevent proper application of a medical sensor and electrode

3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covidien

Boulder, Colorado, United States

Countries

United States

Other Identifiers

COVMOPR0303

Identifier Type: -

Identifier Source: org_study_id