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Induced Hypoxia Study for Validation of SpO2 Accuracy

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: NCT00788983
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : September 20, 2013
Information provided by (Responsible Party):
Nonin Medical, Inc

Brief Summary:
Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).

Condition or disease

Detailed Description:

The testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with the IRB approved Protocol. The subjects shall be distributed across both genders and a range of skin tones as equally as practical.

An arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. The subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

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Study Type : Observational
Actual Enrollment : 12 participants
Time Perspective: Prospective
Official Title: Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia
Study Start Date : November 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Primary Outcome Measures :
  1. SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100% [ Time Frame: During Analysis ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy, consenting, non-smoking subjects, 18 years or greater, both genders and a range of skin tones

Inclusion Criteria:

  • Non-smokers
  • Healthy; no known blood disorders
  • Finger sizes within the sensor specifications
  • Minimum 18 years of age

Exclusion Criteria:

  • Artificial nails or fingernail polish

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): NCT00788983

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United States, California
University of California, San Francisco, Induced Hypoxia Lab
San Francisco, California, United States, 94143
Sponsors and Collaborators
Nonin Medical, Inc
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Principal Investigator: Philip E Bickler, MD University of California, San Francisco

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Responsible Party: Nonin Medical, Inc Identifier: NCT00788983     History of Changes
Other Study ID Numbers: 112008
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: December 2008
Keywords provided by Nonin Medical, Inc:
Induced hypoxia
Pulse oximeter
Nonin Medical
Verification of SpO2 accuracy
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory
Signs and Symptoms