Skip to main content
Clinical Trials/NCT00788983
NCT00788983
Completed
Not Applicable

Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

Nonin Medical, Inc1 site in 1 country12 target enrollmentNovember 2008
ConditionsHypoxia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxia
Sponsor
Nonin Medical, Inc
Enrollment
12
Locations
1
Primary Endpoint
SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100%
Status
Completed
Last Updated
12 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
November 2008
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100%

Time Frame: During Analysis

Study Sites (1)

Loading locations...

Similar Trials