Pulse Oximetry- Evaluating Sensor Off- PCBA-1

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01791569

Enrollment

Registered

2013-02-15

Start date

2012-09-30

Completion date

2012-09-30

Last updated

2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time.	1-2 hours per subject

Countries

United States

Outcome results