Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

This study has been completed.
Sponsor:
Information provided by:
SterilMed, Inc.
ClinicalTrials.gov Identifier:
NCT01253785
First received: December 1, 2010
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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


Condition
Hypoxia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Further study details as provided by SterilMed, Inc.:

Primary Outcome Measures:
  • SpO2 Accuracy Verification Study (Arms) of ≤ 3.0% between 70-100% [ Time Frame: During Analysis - data were collected for all subjects on one day ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  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 ClinicalTrials.gov identifier: NCT01253785

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

No publications provided

Responsible Party: Garrett Ahlborg, SterilMed, Inc.
ClinicalTrials.gov Identifier: NCT01253785     History of Changes
Other Study ID Numbers: STER05
Study First Received: December 1, 2010
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014