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NCT06149416 · ClinicalTrials.gov registry record · NA
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions
A NA study of Healthy and Hypoxia, sponsored by Stryker Sustainability Solutions.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT06149416: Completed NA study of Healthy and Hypoxia, sponsored by Stryker Sustainability Solutions.
NCT06149416 is a NA study of Healthy and Hypoxia that has completed, run by Stryker Sustainability Solutions. The registered enrollment target is 11 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06149416, a NA study of Healthy and Hypoxia, has completed, sponsored by Stryker Sustainability Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.
Primary Outcome
The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry se
Interventions
- DEVICE Experimental Masimo RD SET SpO2 Adhesive Sensors
Study Locations (1)
California
- UCSF Hypoxia Research Laboratory - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2023-05-27 |
| Est. Completion | 2023-05-28 |
| Phase | NA |
What the finished NCT06149416 record still lists
NCT06149416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Experimental Masimo RD SET SpO2 Adhesive Sensors is the first listed.
NCT06149416 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06149416 about?
NCT06149416 is a clinical study titled "SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions". The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. ...
What is the current status of trial NCT06149416?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2023-05-27. Estimated completion is 2023-05-28.
What conditions does trial NCT06149416 study?
This clinical trial studies the following conditions: Healthy, Hypoxia.
What interventions are being tested in trial NCT06149416?
The interventions under investigation include: Experimental Masimo RD SET SpO2 Adhesive Sensors (DEVICE).
Who is sponsoring clinical trial NCT06149416?
This trial is sponsored by Stryker Sustainability Solutions, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06149416 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 NCT06149416's enrollment target sits among peer trials
11 1031st of 1090 higher than 57 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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