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

NCT02846974 | Unknown

• 1 other identifier: 107952
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulse Oximetry; Free and Open Source

Keywords

Pulse Oximetry; Free and Open Source

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Pulse oximeter DEVICE

A pulse oximeter will be used for calibration

Calibration cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• London Health Sciences Centre: collaborator
• Al Shifa Hospital, Gaza: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Study Officials

• Tarek Loubani, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2016
• First Posted: July 27, 2016
• Study Start: September 25, 2019
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2023
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

CA (1)