NCT07615738

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

May 18, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 1, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 18, 2026

Last Update Submit

June 29, 2026

Conditions

SpO2 (Peripheral Oxygen Saturation) Measurement ValidationSpO2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of Safety Events

    4 months

Study Arms (1)

All Subjects

EXPERIMENTAL

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

Interventions

SpO2 SensorDEVICE

SpO2 sensors use red and infrared LED light to estimate the arterial oxygen saturation.

All Subjects

Eligibility Criteria

Age29 Days - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center Children's Hospital

Omaha, Nebraska, 68114, United States

Location

Related Publications (4)

  • 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: 17613642BACKGROUND

  • 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: 36939727BACKGROUND

  • 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: 34772785BACKGROUND

  • 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: 15791098BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 29, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)