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

Pulse Oximetry Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02846974
• Other study ID #: 107952
• Status: Active, not recruiting
• Start date: September 25, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Free and Open Source
• Pulse Oximetry

Intervention

Device:
• Pulse oximeter
A pulse oximeter will be used for calibration

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Al Shifa Hospital, Gaza, London Health Sciences Centre, University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

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