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

NCT01732029 | Completed

• 1 other identifier: H12-02365
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Oxygen Saturation Level; Heart Rate

Keywords

pulse oximeter; oxygen saturation; heart rate; calibration; accuracy

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation

  Accurately calibrated AudioOx for measuring oxygen saturation

  Across 3 hours

Secondary Outcomes (1)

• Heart rate

  Across 3 hours

Study Arms (1)

Normobaric hypoxia chamber

OTHER

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

Interventions

Normobaric hypoxia chamber OTHER

Normobaric hypoxia chamber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 22, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

CA (1)