NCT02846974

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulse Oximetry
• Free and Open Source

Interventions

Type	Name	Description
DEVICE	Pulse oximeter	A pulse oximeter will be used for calibration

Timeline

• Start date: 2019-09-25
• Primary completion: 2023-07-01
• Completion: 2023-12-31
• First posted: 2016-07-27
• Last updated: 2022-08-25

Locations

1 site across 1 country: Canada