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OpenTrials
Completed

NCT Number: NCT07352033

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

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.

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Key information

Age range

2 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masimo Radical-7® Pulse CO-Oximeter

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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