Pulse Oximetry- Evaluating Sensor Off- PCBA-1

Healthy Subjects Clinical Trial

Official title:

Sensor Off Studies Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791569
• Other study ID #: COVMOPR0303
• Status: Completed
• Phase: N/A
• First received: November 29, 2012
• Last updated: December 5, 2013
• Start date: September 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
United States	Covidien	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time.		1-2 hours per subject	No