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NCT04889222 · ClinicalTrials.gov registry record
Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters
A clinical trial, sponsored by Masimo Corporation.
- Terminated
- Registry status
- 54
- Enrollment target
NCT04889222: Clinical Trial study, sponsored by Masimo Corporation.
NCT04889222 is a clinical trial that was terminated before completion, run by Masimo Corporation. The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04889222 was terminated before completion, sponsored by Masimo Corporation.
- TERMINATED
- Registry status
- 54 participants
- Enrollment target
Study Summary
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Subgroups will be analyzed by skin pigmentation and self-identified race/ethnicity information. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
Primary Outcome
Performance of the INVSENSOR00050 sensor will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the accuracy root mean square (ARMS) value. The ARMS value will be reported as % of oxygen saturated hemoglobin.
Interventions
- DEVICE INVSENSOR00050
- DEVICE RD SET SpO2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-04-05 |
| Est. Completion | 2021-04-29 |
Why NCT04889222 stopped before completion
NCT04889222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which INVSENSOR00050 is the first listed.
NCT04889222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04889222 about?
NCT04889222 is a clinical study titled "Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters". This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Subgroups will be analyzed by skin pigmentation and self-identified race/ethnicity information. Study procedures follow ISO-8060...
What is the current status of trial NCT04889222?
This trial is currently terminated. The enrollment target is 54 participants. The study started on 2021-04-05. Estimated completion is 2021-04-29.
What interventions are being tested in trial NCT04889222?
The interventions under investigation include: INVSENSOR00050 (DEVICE), RD SET SpO2 (DEVICE).
Who is sponsoring clinical trial NCT04889222?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
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