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NCT04811963 · ClinicalTrials.gov registry record
SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor
A clinical trial, sponsored by Medtronic - MITG.
- Completed
- Registry status
- 10
- Enrollment target
NCT04811963: Completed study, sponsored by Medtronic - MITG.
NCT04811963 is a clinical trial that has completed, run by Medtronic - MITG. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04811963 has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
Primary Outcome
To validate the proposed claims for saturation accuracy in a diverse subject population during Low Saturation over a specified saturation range. The acceptance criteria for the OxySoftN Sensor SpO2 during Low Saturation conditions across the saturation range of 60-80% when paired with the N-600x, PM1000N and Oxicable: SpO2 OxySoftN ± 3% (Arms)
Interventions
- DEVICE Non-Invasive Controlled Hypoxia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-04-06 |
| Est. Completion | 2021-04-09 |
What the finished NCT04811963 record still lists
NCT04811963 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 Non-Invasive Controlled Hypoxia is the first listed.
NCT04811963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04811963 about?
NCT04811963 is a clinical study titled "SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor". To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.
What is the current status of trial NCT04811963?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2021-04-06. Estimated completion is 2021-04-09.
What interventions are being tested in trial NCT04811963?
The interventions under investigation include: Non-Invasive Controlled Hypoxia (DEVICE).
Who is sponsoring clinical trial NCT04811963?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
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