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Completed

NCT Number: NCT01791569

Pulse Oximetry- Evaluating Sensor Off- PCBA-1

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

Completed

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Covidien

Boulder, Colorado, 80301, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects 18 or older (inclusive).
  • Subject is able to participate for the duration of the study
  • Subject is willing to sign an informed consent

Exclusion criteria

  • Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
  • Physiologic abnormalities that prevent proper application of a medical sensor and electrode
  • Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

Treatment and study plan

Primary outcomes

  1. Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time.

    Time frame: 1-2 hours per subject

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2013
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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