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

• Conditions: Free and Open Source; Pulse Oximetry
• Interventions: Device: Pulse oximeter

• Registration Number: NCT02846974
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-23
• Study First Submitted QC: 2016-07-23
• Study First Posted: 2016-07-27
• Study Start: 2019-09-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25
• Primary Completion: 2023-07
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Calibration cohort	Pulse oximeter	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
Validation cohort	Pulse oximeter	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada