SpO2 Infant and Pediatric Study (SpO2 Peds)

Assessment of TruSignal SpO2 Form, Fit and Clinical Performance With Infant and Child Patients

This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years). It compares SpO₂ measurements from the device to arterial oxygen saturation (SaO₂) values from arterial CO-oximetry, and assesses the reliability of usable data, performance across skin tones, and user feedback.

Study Overview

• Status: Not yet recruiting
• Conditions: SpO2; SpO2 (Peripheral Oxygen Saturation) Measurement Validation
• Intervention / Treatment: Device: SpO2 Sensor

Detailed Description

This prospective clinical study evaluates a pulse oximetry sensor in hospitalized infants (28 days to 23 months) and children (2-12 years) under routine clinical conditions. The primary objective is to assess the accuracy and agreement of SpO₂ measurements compared with reference SaO₂ values obtained from CO-oximetry analysis of simultaneously drawn arterial blood, using methods aligned with ISO 80601-2-61 (3rd edition CD draft) and FDA draft guidance.

Secondary objectives include measuring the proportion of time the device produces invalid or unusable data to assess reliability for clinical use. The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues. Results may support product development, regulatory submissions, and marketing activities.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • University of Nebraska Medical Center Children's Hospital
      • Contact: Michael Facciolo, MD; Phone Number: 402-671-6325; Email: mfacciolo@childrensnebraska.org
      • Principal Investigator: Michael Facciolo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• subjects are 1-23 months (infant cohort) or 2-12 years old (pediatric cohort)
• requiring arterial blood samples per the site's standard of care.

Exclusion Criteria:

• Fractional Methemoglobinemia (FMetHb >2%) or Fractional carboxyhemoglobinemia (FCOHb >3%), within 24 hours of arterial blood draw.
• Severe anemia (tHb <7g/dL) within 4 hours prior to arterial blood gas draw.
• Hematocrit (Hct) <25 within 4 hours prior to arterial blood gas draw.
• Patients with injuries, deformities, or abnormalities which may prevent proper application of the sensor.
• Patients on Extracorporeal Membrane Oxygenation (ECMO).
• Patients receiving point of care (POC) testing for blood gases.
• Patients with diseases/conditions that may cause differential (or reverse differential) cyanosis including, but not limited to:
• Patent ductus arteriosus with pulmonary arterial hypertension.
• Pulmonary hypertension and left-heart abnormalities aortic arch hypoplasia, interrupted aortic arch, critical coarctation, and critical aortic stenosis.
• Children with transposition of the great arteries (TGA) and coarctation of the aorta or interrupted aortic arch, and TGA with suprasystemic pulmonary vascular resistance.
• At the discretion of the principal investigator or designee due to the subject health condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Subjects; Participants participating in this study will be connected to SpO2 sensors. SpO2 data will be independently collected from each sensor and paired with simultaneous arterial blood sample SaO₂ values. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.	Device: SpO2 Sensor; SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 values	The collection of SpO2 percentage sensor data with simultaneous SaO2 values percentage from each subject enrolled in the study.	From enrollment to the end of standard of care arterial cannulation, approximately 1 week.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Safety Events	Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events.	4 months

Collaborators and Investigators

• Sponsor: GE Healthcare

Publications and helpful links

General Publications

• Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.
• Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004.
• Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12.
• Ruppel H, Makeneni S, Faerber JA, Lane-Fall MB, Foglia EE, O'Byrne ML, Bonafide CP. Evaluating the Accuracy of Pulse Oximetry in Children According to Race. JAMA Pediatr. 2023 May 1;177(5):540-543. doi: 10.1001/jamapediatrics.2023.0071.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SA-000192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No