Viewing Study NCT06372106



Ignite Creation Date: 2024-05-06 @ 8:25 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06372106
Status: RECRUITING
Last Update Posted: 2024-07-03
First Post: 2024-03-29

Brief Title: Project Mountain - Comparing SpO2 and SaO2 for Accuracy
Sponsor: Philips Clinical Medical Affairs Global
Organization: Philips Clinical Medical Affairs Global

Study Overview

Official Title: Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate Infant and Pediatric Patients
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None