NCT06372106

Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate, Infant, and Pediatric Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 560 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• SpO2
• Nasal Alar Collapse, Bilateral
• Oxygen
• Measurement

Interventions

Type	Name	Description
DEVICE	SaO2 Sampling	CO-Oximetry analysis of arterial blood samples

Timeline

• Start date: 2024-04-04
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-04-17
• Last updated: 2025-04-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study