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NCT05581394 · ClinicalTrials.gov registry record
Accuracy of BabySat V3 With Profound Hypoxia and Motion
A clinical trial of Hypoxia, sponsored by Owlet Baby Care.
- Completed
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT05581394: Completed study of Hypoxia, sponsored by Owlet Baby Care.
NCT05581394 is a study of Hypoxia that has completed, run by Owlet Baby Care. The registered enrollment target is 12 participants, below the 3,117-participant average among 39 other Hypoxia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05581394, a study of Hypoxia, has completed, sponsored by Owlet Baby Care.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Primary Outcome
Determine the accuracy during varying degrees of motion and oxygen saturation
Conditions Studied
Interventions
- DEVICE BabySat V3
Study Locations (1)
California
- University California San Fransisco, Department of Anesthesia - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-07-14 |
| Est. Completion | 2022-07-15 |
What the finished NCT05581394 record still lists
NCT05581394 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 3,117-participant average among 39 other Hypoxia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Hypoxia appearing as the primary indexed condition, and to 1 intervention - of which BabySat V3 is the first listed.
NCT05581394 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05581394 about?
NCT05581394 is a clinical study titled "Accuracy of BabySat V3 With Profound Hypoxia and Motion". Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a ...
What is the current status of trial NCT05581394?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2022-07-14. Estimated completion is 2022-07-15.
What conditions does trial NCT05581394 study?
This clinical trial studies the following conditions: Hypoxia.
What interventions are being tested in trial NCT05581394?
The interventions under investigation include: BabySat V3 (DEVICE).
Who is sponsoring clinical trial NCT05581394?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05581394 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05581394's enrollment target sits among peer trials
12 30th of 39 higher than 3 of 39 other Hypoxia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoxia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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