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Accuracy of Continuous SpO2 Measurement in Adults (SPO2)

This study has been withdrawn prior to enrollment.
Information provided by:
Sotera Wireless, Inc. Identifier:
First received: August 13, 2010
Last updated: June 21, 2011
Last verified: June 2011
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.


Study Type: Observational
Study Design: 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

Further study details as provided by Sotera Wireless, Inc.:

Estimated Enrollment: 15
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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: August 13, 2010
Last Updated: June 21, 2011

Keywords provided by Sotera Wireless, Inc.:
Oxygen saturation processed this record on August 18, 2017