- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05895682
A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers
June 6, 2023 updated by: Seers Technology Co., Ltd.
It is important to evaluate the accuracy of the pulse oximeter, which is commonly used in clinical practice.
The US FDA only allows the use of devices that meet the ISO 80601-2-61:2017 standard in the United States.
According to the ISO 80601-2-61:2017 standard, the accuracy of the oxygen saturation (SpO2) of the pulse oximeter should have an error range of less than 4.0% compared to the actual arterial blood oxygen saturation (SaO2) in the range of 70-100%.
To prove compliance with this requirement, it is necessary to conduct a clinical trial that induces hypoxemia in healthy adults and compares and evaluates the arterial blood oxygen saturation values of the pulse oximeter's SpO2 and the arterial blood oxygen saturation values of the carbon monoxide-oxygen meter (CO-oximeter).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gyeonggi-do
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Pyeongtaek-si, Gyeonggi-do, Korea, Republic of, 17707
- Seers Technology Co., Ltd.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy adults between 20 and 50 years
- volunteers who have plasma proportion of carboxyhemoglobin 3%
- volunteers who have plasma proportion of methemoglobin 2%
- volunteers who have total plasma hemoglobin concentration over 10 g/dL
Exclusion Criteria:
- History of respiratory diseases
- History of cardiovascular disease
- Smokers (including ex-smokers)
- Pregnant
- History of fainting
- History of diabetes
- Obesity (BMI> 30 kg/m2)
- Allen's test results, those who do not recover the color of their fingers and palms within 10 seconds
- History of allergic reaction to lidocaine, a local anesthetic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Induced hypoxia
Volunteers were monitored using end-tidal carbon dioxide partial pressure and fraction of inspired oxygen.
Each volunteer was placed in a semi-Fowler's position and connected to a breathing circuit to administer the nitrogen-air-carbon dioxide mixtures.
A nose clip was applied to prevent breathing of room air.
For frequent blood sampling, an arterial cannula was placed in the radial artery of each volunteer.
Pulse oximeter probes were simultaneously attached to each volunteer's fingers.
Each volunteer was exposed to various levels of induced hypoxia from 70~100% of SaO2.
Each plateau of oxygen saturation was maintained for at least 30 s until stabilization, after which 1 ml of arterial blood was drawn into a heparinized syringe.
The study period consisted of two rounds of hypoxia, and the volunteers were maintained on room air between each round.
SaO2 measurements using a CO-oximeter were used as a reference for the SpO2 accuracy.
|
Volunteers were monitored using end-tidal carbon dioxide partial pressure and fraction of inspired oxygen.
Each volunteer was placed in a semi-Fowler's position and connected to a breathing circuit to administer the nitrogen-air-carbon dioxide mixtures.
A nose clip was applied to prevent breathing of room air.
For frequent blood sampling, an arterial cannula was placed in the radial artery of each volunteer.
Pulse oximeter probes were simultaneously attached to each volunteer's fingers.
Each volunteer was exposed to various levels of induced hypoxia from 70~100% of SaO2.
Each plateau of oxygen saturation was maintained for at least 30 s until stabilization, after which 1 ml of arterial blood was drawn into a heparinized syringe.
The study period consisted of two rounds of hypoxia, and the volunteers were maintained on room air between each round.
SaO2 measurements using a CO-oximeter were used as a reference for the SpO2 accuracy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of SpO2
Time Frame: 2 day
|
The root-mean-square of the difference between the observed pulse oximetry value (SpO2) and the carbon monoxide-oxygenometer arterial blood reference value (SRi) within the range of 70-100% of arterial oxygen saturation
|
2 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2023
Primary Completion (Actual)
May 14, 2023
Study Completion (Actual)
May 15, 2023
Study Registration Dates
First Submitted
May 21, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 8, 2023
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-1657
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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