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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02846974
Other study ID # 107952
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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