Convenience Sample Data Collection for INVSENSOR00045
Terminated
- Conditions
- Oxygen Saturation
- Registration Number
- NCT04894669
- Lead Sponsor
- Masimo Corporation
- Brief Summary
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- Less than or equal to 1 month of age
- Gestational age greater than 23 weeks
- Weight less than or equal to 5 kg
- Subjects with standard of care arterial blood sampling line already in place
Exclusion Criteria
- Subjects with underdeveloped skin
- Subjects with abnormalities at the planned application sites that would interfere with system measurements
- Subjects with known allergic reactions to foam/rubber products and adhesive tape
- Subjects with axillary arterial lines
- Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Form, Fit and Function of INVSENSOR00045. Up to 8 hours per subject. To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Site 2
🇺🇸Orange, California, United States