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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 is a clinical trial that was terminated before completion, run by Masimo Corporation. The registered enrollment target is 54 participants.
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%.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04889222
The ClinicalTrials.gov registry entry for NCT04889222 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masimo Corporation, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which INVSENSOR00050 is the first listed.
NCT04889222 reports 0 study locations.
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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