Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation

NCT06148623

Healthy

COMPLETED NA

Accuracy of Pulse Oximeters During Profound Hypoxia

NCT05790616

Hypoxia

UNKNOWN NA

SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry

NCT03630016

Hypoxia

COMPLETED NA

Accuracy of Pulse Oximeter With Hypoxemic Measurements

NCT02712606

Cyanotic Congenital Heart Disease

COMPLETED

Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease

NCT02237014

Cyanotic Heart Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

SpO2 Nasal Alar Collapse, Bilateral Oxygen Measurement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

* Subject aged 18 years or older or parent/legal guardian of subject aged less than 18 years, willing and able to understand and provide written informed consent/assent.
* Weight and/or age within intended use of at least one SpO2 sensor under test at time of enrollment.
* Willing and able to wear study devices in addition to SoC devices and during SoC procedures.
* In-patient within a neonatal or pediatric intensive care unit (e.g. NICU, PICU, PCICU).
* Has arterial access and ability to have arterial blood samples drawn as part of their SoC and analyzed by CO-Oximetry.

Exclusion Criteria

* Known pregnancy or lactating females (self-reported)
* Injury, wounds, physical malformation, hyperkeratosis, or compromised/non-intact skin at sensor application site (i.e. fingers, toes, hands, feet, ears, nasal ala). Note: Certain malformations may be allowed if determined it would not affect application of sensor with the pulse oximetry system.
* Self-reported severe contact allergies to standard adhesives or other materials found in pulse oximetry sensors. Note: Subject may be considered eligible if subject can wear non-adhesive sensor.
* Unwillingness or inability to remove nail polish or artificial nails from sensor application site.
* Nail fungus on sensor application site.
* Wearing and unable to remove jewelry from sensor application site.
* Dye injection within 48 hours of enrollment.
* Known dysfunctional hemoglobin levels (COHb \>3%, MetHb \>2%, and ctHb \<10g/dl)
* Undergoing phototherapy for neonatal hyperbilirubinemia during arterial blood sampling

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes