NCT07352033

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 11, 2026

Last Update Submit

January 11, 2026

Conditions

Anemia (Diagnosis)

Outcome Measures

Primary Outcomes (1)

  • Agreement and Correlation between Non-invasive Hemoglobin (SpHb) and Invasive Arterial Hemoglobin (Hb) levels.

    Intraoperative period (from induction of anesthesia to extubation, approximately 2-5 hours

Study Arms (1)

Pediatric Neurosurgery Patients

Pediatric patients undergoing neurosurgical procedures requiring invasive arterial pressure monitoring and hemoglobin measurement

Device: Masimo Radical-7® Pulse CO-Oximeter

Interventions

Masimo Radical-7® Pulse CO-OximeterDEVICE

Continuous non-invasive measurement of total hemoglobin (SpHb) using a pulse co-oximetry sensor during the surgery.

Pediatric Neurosurgery Patients

Eligibility Criteria

Age2 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AnemiaDisease

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2026

First Posted

January 20, 2026

Study Start

December 1, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

TU(1)