Calibration and Evaluation of an Audio Pulse Oximeter Sensor (AudioOx) at Ascent and Descent From Simulated Altitude

This study is currently recruiting participants.
Verified August 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01732029
First received: November 16, 2012
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

Pulse oximetry is a standard non-invasive method of measuring blood oxygen saturation (SpO2). In developing countries, pulse oximeters are rare because of expense and electricity requirements. Our ECEM group has developed the Phone Oximeter, which uses a cell phone (which are widely available in developing countries) to compute and analyze information from a pulse oximeter sensor. To further reduce costs, we have developed an oximeter sensor (AudioOx) that plugs into the audio jack of a standard cell phone. This study aims to calibrate the AudioOx by exposing 30 healthy adult volunteers to various altitudes in UBC's hypoxia chamber.


Condition Intervention Phase
Blood Oxygen Saturation Level
Heart Rate
Other: Normobaric hypoxia chamber
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Calibration and Evaluation of an Audio Pulse Oximeter Sensor (AudioOx) at Ascent and Descent From Simulated Altitude

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Oxygen saturation [ Time Frame: Across 3 hours ] [ Designated as safety issue: No ]
    Accurately calibrated AudioOx for measuring oxygen saturation


Secondary Outcome Measures:
  • Heart rate [ Time Frame: Across 3 hours ] [ Designated as safety issue: No ]
    Accurately calibrated AudioOx for measuring heart rate


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Normobaric hypoxia chamber
Study subjects will be put into a hypoxic state by exposing them to normobaric hypoxia by administrating an air mix containing a reduced O2 concentration. This is achieved in a hypoxia chamber where O2 concentration is gradually reduced to simulate high altitude (about 4500 m).
Other: Normobaric hypoxia chamber

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smokers
  • UBC students age 18 and older or non-university students age 19 and older
  • No medical history of respiratory, cardiovascular and neurological problems (capable of undergoing controlled hypoxemia down to SpO2 of 70%).

Exclusion Criteria:

  • Medical history including respiratory, cardiovascular and neurological problems
  • Smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels (interferes with oximetry readings)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732029

Contacts
Contact: Heng Gan, Dr 604-875-2711 heng.gan@cw.bc.ca
Contact: Dorothy Myers 604-875-2000 ext 5319 dmyers2@cw.bc.ca

Locations
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Heng Gan, Dr    604-875-2711    heng.gan@cw.bc.ca   
Contact: Dorothy Myers    604-875-2000 ext 5319    dmyers2@cw.bc.ca   
Principal Investigator: Mark Ansermino, Dr         
Sub-Investigator: Guy Dumont, Dr         
Sub-Investigator: Heng Gan, Dr         
Sub-Investigator: Chris Peterson, Dr         
Sub-Investigator: Walter Karlen, Dr         
Sub-Investigator: James Rupert, Dr         
Sub-Investigator: Michael Koehle, Dr         
Sub-Investigator: Martin MacInnis         
Sponsors and Collaborators
University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01732029     History of Changes
Other Study ID Numbers: H12-02365
Study First Received: November 16, 2012
Last Updated: August 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
pulse oximeter
oxygen saturation
heart rate
calibration
accuracy

ClinicalTrials.gov processed this record on April 17, 2014