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

NCT ID: NCT02846974

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2023-12-31

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Pulse oximeter

Intervention Type: DEVICE

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.

Pulse oximeter

Intervention Type: DEVICE

A pulse oximeter will be used for calibration

Interventions

Pulse oximeter

A pulse oximeter will be used for calibration

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

Al Shifa Hospital, Gaza

UNKNOWN

Sponsor Role: collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Tarek Loubani, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Loubani, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

107952

Identifier Type: -

Identifier Source: org_study_id