Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
NCT ID: NCT06120777
Last Updated: 2024-11-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
89 participants
INTERVENTIONAL
2023-11-01
2023-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Test Subject
All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.
INVSENSOR00069
Noninvasive pulse oximeter
Interventions
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INVSENSOR00069
Noninvasive pulse oximeter
Eligibility Criteria
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Inclusion Criteria
* Subject is 18 to 50 years of age.
* Subject weighs a minimum of 110 lbs.
* Hemoglobin value ≥ 11 g/dL.
* Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
* Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
* CO value ≤ 3.0% FCOHb.
* Subject is comfortable to read and communicate in English\*. \*This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.
Exclusion Criteria
* Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
* Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
* Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).
Influenced by study design/environment:
* Subjects who do not pass the health assessment for safe participation in the study procedures.
* Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.
18 Years
50 Years
ALL
Yes
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Masimo Corporation
Irvine, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CIP-1086
Identifier Type: -
Identifier Source: org_study_id