Induced Hypoxia Study for Validation of SpO2 Accuracy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc
ClinicalTrials.gov Identifier:
NCT00788983
First received: November 7, 2008
Last updated: September 19, 2013
Last verified: December 2008
  Purpose

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
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 Nonin Medical, Inc:

Primary Outcome Measures:
  • SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100% [ Time Frame: During Analysis ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 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 greater, both genders and a range of skin tones

Criteria

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
  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: NCT00788983

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

No publications provided

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT00788983     History of Changes
Other Study ID Numbers: 112008
Study First Received: November 7, 2008
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nonin Medical, Inc:
Induced hypoxia
Pulse oximeter
Nonin Medical
Verification of SpO2 accuracy

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

ClinicalTrials.gov processed this record on August 28, 2014