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Accuracy of Continuous SpO2 Measurement in Adults (SPO2)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Sotera Wireless, Inc.
ClinicalTrials.gov Identifier:
NCT01183338
First received: August 13, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Healthy

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

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183338

Locations
United States, Colorado
Clinimark Desaturation Laboratory
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Sotera Wireless, Inc.
Investigators
Principal Investigator: Philip S. Clifford, PhD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Gary Manning, Vice President Clinical Affairs and Business Development, Sotera Wireless, Inc.
ClinicalTrials.gov Identifier: NCT01183338     History of Changes
Other Study ID Numbers: SWI-US11-006
Study First Received: August 13, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sotera Wireless, Inc.:
SpO2
Oxygen saturation

ClinicalTrials.gov processed this record on June 17, 2013