Status:
COMPLETED
Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.
Eligibility Criteria
Inclusion
- Influenced by study design:
- 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
- Influenced by device warning labels:
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT06120777
Start Date
November 1 2023
End Date
December 12 2023
Last Update
November 27 2024
Active Locations (1)
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1
Masimo Corporation
Irvine, California, United States, 92618