Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter

Pulse oximetry is a vital tool in the rapid and non-invasive assessment of emergency patients, providing a continuous estimate of hemoglobin saturation in arterial blood. Unfortunately, the costs of these devices are prohibitive and reduce availability in smaller centres and poor countries, putting millions of patients in danger of easily treatable and preventable conditions. With current rapid prototyping technologies such as 3D printing, it is possible to create a very inexpensive pulse oximeter that meets or exceeds the gold standard. The goal of this study is to develop, validate and certify a pulse oximeter that measures hemoglobin, carboxyhemoglobin and methemoglobin. This pulse oximeter will be certified with Health Canada, and then released under the Open Hardware License (OHL), such that hospitals and ministries of health in rural and impoverished communities in Canada and internationally would have easy access to these devices.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulse Oximetry; Free and Open Source
• Intervention / Treatment: Device: Pulse oximeter

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study has 2 Phases. In Phase 1, healthy, non-smoking adult volunteers greater than 18 years of age are invited to participate. In Phase 2, all adult (>18) non-critical patients and healthy community volunteers visiting the emergency department at Victoria Hospital and University Hospital are eligible to participate.

Description

Inclusion Criteria:

- This study has 2 Phases. In Phase 1, healthy, non-smoking adult volunteers greater than 18 years of age are invited to participate. In Phase 2, all adult (>18) non-critical patients and healthy community volunteers visiting the ED at VH and UH are eligible to participate.

Exclusion Criteria:

Potential participants will be excluded based on the following criteria:

Phase 1:

• greater than 70 years of age,
• current smokers,
• previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure),
• history of moderate or severe asthma,
• history of seizures,
• history of stroke or transient ischemic attack
• pregnant women
• Patients with any active pulmonary disease such as pneumonia
• Individuals who are unwilling to participate or are less than 18 years old
• Those who are unable to consent

Phase 2

• Critical patients will be excluded from participating
• Individuals who are unwilling to participate or are less than 18 years old will be excluded
• Those who are unable to consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Calibration cohort; In this cohort, approximately 30 subjects will be put through a controlled desaturation study with controlled hypoxia until they arrive at approximately SpO2 = 70%. Measurements will be taken via arterial catheterization to resolve proper values to calibrate the device	Device: Pulse oximeter; A pulse oximeter will be used for calibration
Validation cohort; In this cohort, approximately 250 patients will have a single pulse oximetry reading taken using the novel device and a gold standard device to ensure accurate validation.	Device: Pulse oximeter; A pulse oximeter will be used for calibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse oximetry reading	Pulse oximetry readings will be taken over the span of an hour to calibrate the device	1 hour
Arterial blood gas	Arterial blood gases will be taken to create a proper calibration curve along with the device's readings.	1 hour

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: University of Western Ontario, Canada; London Health Sciences Centre; Al Shifa Hospital, Gaza
• Investigators: Principal Investigator: Tarek Loubani, MD, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 23, 2016
• First Submitted That Met QC Criteria: July 23, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pulse Oximetry; Free and Open Source
• Other Study ID Numbers: 107952