Is Pulse Co-Oximetry a Reliable Alternative to Invasive Hemoglobin Measurement in Pediatric Neurosurgical Procedures?

January 11, 2026 updated by: FUNDA ARUN, Selcuk University
The study evaluated the diagnostic accuracy and clinical utility of continuous SpHb across a comprehensive pediatric age spectrum-ranging from neonates to adolescents-undergoing high-risk neurosurgical procedures (cranial and spinal) characterized by significant potential for blood loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Selçuklu
      • Konya, Selçuklu, Turkey (Türkiye), 42130
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients admitted to the Department of Neurosurgery for elective surgery requiring general anesthesia and invasive arterial blood pressure monitoring.

Description

Inclusion Criteria:

  • ASA I-IV,
  • Scheduled for elective complex spinal surgery or cranial procedures under general anesthesia

Exclusion Criteria:

  • congenital heart disease
  • requirement for emergency surgery
  • pre-existing peripheral circulatory disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Neurosurgery Patients
Pediatric patients undergoing neurosurgical procedures requiring invasive arterial pressure monitoring and hemoglobin measurement
Device: Masimo Radical-7® Pulse CO-Oximeter
Continuous non-invasive measurement of total hemoglobin (SpHb) using a pulse co-oximetry sensor during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Agreement and Correlation between Non-invasive Hemoglobin (SpHb) and Invasive Arterial Hemoglobin (Hb) levels.
Time Frame: Intraoperative period (from induction of anesthesia to extubation, approximately 2-5 hours
Intraoperative period (from induction of anesthesia to extubation, approximately 2-5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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