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Clinical Trial Summary

The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation.


Clinical Trial Description

This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06372106
Study type Observational
Source Philips Clinical & Medical Affairs Global
Contact Dhaval Patel
Phone 508-907-2304
Email dhaval.patel@philips.com
Status Not yet recruiting
Phase
Start date April 2024
Completion date December 2024

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