Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Oxygen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372106
• Other study ID #: MA_PM_Mountain_2022_11496
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: Dhaval Patel
• Phone: 508-907-2304
• Email: dhaval.patel[@]philips.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• SaO2 Sampling
CO-Oximetry analysis of arterial blood samples

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth.	The oximetry technology will be expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth.	through study completion, an average of 8 months
Secondary	Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology.	Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology.	through study completion, an average of 8 months
Secondary	Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 =92%) is identified among patients within the broad categories of light, medium, and dark pigmentation.	Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 =92%) is identified among patients within the broad categories of light, medium, and dark pigmentation.	through study completion, an average of 8 months