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Trial record 53 of 620 for:    oximeter

Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

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: NCT01253785
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 3, 2010
Information provided by:
SterilMed, Inc.

Brief Summary:
Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.

Condition or disease

Detailed Description:

The testing is conducted on 10 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 : 10 participants
Time Perspective: Prospective
Official Title: Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia
Study Start Date : May 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Primary Outcome Measures :
  1. SpO2 Accuracy Verification Study (Arms) of ≤ 3.0% between 70-100% [ Time Frame: During Analysis - data were collected for all subjects on one day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 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 older, both genders and a range of skin tones.

Inclusion Criteria:

  • Non-smoker
  • 18 years or older
  • Meet the requirements of the investigator's medical history questionnaire criteria which described family history, present symptoms, smoking history, risk factors, nutrition, exercise levels and stress levels
  • Understand and provide signed consent for the procedure

Exclusion Criteria:

  • Smoker
  • User of illegal drugs
  • Hypertension
  • Respiratory disease
  • Known allergy to Lidocaine or its derivatives
  • Those suffering from upper respiratory infection on the day of 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): NCT01253785

Sponsors and Collaborators
SterilMed, Inc.
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Principal Investigator: Phillip E Bickler, MD, PhD University of California, San Francisco

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Responsible Party: Garrett Ahlborg, SterilMed, Inc. Identifier: NCT01253785     History of Changes
Other Study ID Numbers: STER05
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory
Signs and Symptoms