SpO2 Infant and Pediatric Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SpO2 Sensor.
- Who it may be relevant to
- Registry conditions: SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2. Basic parameters: 29 Days — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of TruSignal SpO2 Form, Fit and Clinical Performance With Infant and Child Patients
Overview
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.
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: 2026 3rd edition published in April 2026.
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.
Interventions
- Device SpO2 Sensor
SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.
Primary outcome measures
- Collection of SpO2 Percentage Sensor Data with simultaneous SaO2 values [Time frame: From enrollment to the end of standard of care arterial cannulation, approximately 1 week.]
Eligibility criteria
Inclusion criteria
- subjects are 1-23 months (infant cohort) or 2-12 years old (child 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- University of Nebraska Medical Center Children's Hospital — Omaha
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. PMID 17613642
- 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. PMID 36939727
- 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. PMID 34772785
- 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. PMID 15791098
Identifiers
NCT: NCT07615738 · SA-000192