Calibration and Evaluation of an Audio Pulse Oximeter Sensor (AudioOx) at Ascent and Descent From Simulated Altitude
This study is currently recruiting participants.
Verified January 2013 by University of British Columbia
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01732029
First received: November 16, 2012
Last updated: January 9, 2013
Last verified: January 2013
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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 |
Show Detailed Description 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: | January 9, 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 May 19, 2013