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NCT04873947 · ClinicalTrials.gov registry record
Belun SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry
A clinical trial, sponsored by Belun Technology Company Limited.
- Completed
- Registry status
- 10
- Enrollment target
NCT04873947: Completed study, sponsored by Belun Technology Company Limited.
NCT04873947 is a clinical trial that has completed, run by Belun Technology Company Limited. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04873947 has completed, sponsored by Belun Technology Company Limited.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. Testing was conducted under normal office environment conditions.
Primary Outcome
Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70%. The goal was to have an equal distribution of data by decade. The stable plateaus allowed data collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 70-75. In general, 4 to 8 discrete points were collected at each of the levels.
Interventions
- DEVICE Pulse Oximeter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2020-08-28 |
What the finished NCT04873947 record still lists
NCT04873947 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Pulse Oximeter is the first listed.
NCT04873947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04873947 about?
NCT04873947 is a clinical study titled "Belun SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry". This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by funct...
What is the current status of trial NCT04873947?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2020-08-25. Estimated completion is 2020-08-28.
What interventions are being tested in trial NCT04873947?
The interventions under investigation include: Pulse Oximeter (DEVICE).
Who is sponsoring clinical trial NCT04873947?
This trial is sponsored by Belun Technology Company Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
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