Accuracy of Continuous SpO2 Measurement in Adults (SPO2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01183338
Recruitment Status : Withdrawn
First Posted : August 17, 2010
Last Update Posted : June 22, 2011
Information provided by:
Sotera Wireless, Inc.

Brief Summary:
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.

Condition or disease

Detailed Description:

This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.

SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.

Study Type : Observational
Estimated Enrollment : 15 participants
Time Perspective: Prospective
Official Title: SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adult volunteers, male or female, of any ethnic background. To the extent possible while still achieving timely enrollment, subjects should vary from one another in their physical characteristics. Each subject must also meet all of the inclusion and exclusion criteria prior to study entry and give informed consent to participate in this study.

Inclusion Criteria:

  • Subject is at least 18 years of age.
  • Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
  • Subject is willing and able to participate in the measurement period for up to two hours.

Exclusion Criteria:

  • Subject has a carboxyhemoglobin level (COHb) ≥3%.
  • Subject has a MetHb level ≥2%.
  • Subject has a ctHb value ≤10g/dl.
  • Subject is in another clinical study that may interfere with the results of this study.
  • Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
  • Subject is deemed by the Investigator to be medically unsuitable for participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01183338

United States, Colorado
Clinimark Desaturation Laboratory
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Sotera Wireless, Inc.
Principal Investigator: Philip S. Clifford, PhD VA Office of Research and Development

Responsible Party: Gary Manning, Vice President Clinical Affairs and Business Development, Sotera Wireless, Inc. Identifier: NCT01183338     History of Changes
Other Study ID Numbers: SWI-US11-006
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Sotera Wireless, Inc.:
Oxygen saturation