Pulse OximetryNCT02846974
Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter
An observational study of Pulse Oximetry and Free and Open Source, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximetry, Free and Open Source
- What is being tested?
- Pulse oximeter
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Pulse oximeter
- Keywords
- Pulse Oximetry, Free and Open Source
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterDevice
A pulse oximeter will be used for calibration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oximetry reading
Pulse oximetry readings will be taken over the span of an hour to calibrate the device
Measured: 1 hour
Arterial blood gas
Arterial blood gases will be taken to create a proper calibration curve along with the device's readings.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start25 Sep 2019
- Primary completionJul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse OximetryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre, Al Shifa Hospital, Gaza, University of Western Ontario, Canada
- Responsible party
- Principal investigator, Tarek Loubani, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Tarek Loubani, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846974
- Sponsor's protocol ID
- 107952
- Status last verified
- Aug 2022
- First submitted
- 23 Jul 2016
- Last updated
- 25 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter
- ClinicalTrials.gov ID
- NCT02846974
- Acronym / sponsor ID
- 107952
- Conditions
- Pulse Oximetry, Free and Open Source
- Keywords
- Pulse Oximetry, Free and Open Source
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- London Health Sciences Centre, Al Shifa Hospital, Gaza, University of Western Ontario, Canada
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calibration cohort | – | Device: Pulse oximeterIn 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 |
| Validation cohort | – | Device: Pulse oximeterIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeterA pulse oximeter will be used for calibration | Device | Calibration cohort, Validation cohort |
Primary outcome
Pulse oximetry reading
Time frame: 1 hour
Pulse oximetry readings will be taken over the span of an hour to calibrate the device
Arterial blood gas
Time frame: 1 hour
Arterial blood gases will be taken to create a proper calibration curve along with the device's readings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Loubani, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulse Oximetry and Free and Open Source, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oximetry reading (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.