Anemia (Diagnosis)NCT07352033
Is Pulse Co-Oximetry a Reliable Alternative to Invasive Hemoglobin Measurement in Pediatric Neurosurgical Procedures?
An observational study of Anemia (Diagnosis), run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 16 years
- Conditions the study is for
- Anemia (Diagnosis)
- What is being tested?
- Masimo Radical-7® Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients admitted to the Department of Neurosurgery for elective surgery requiring general anesthesia and invasive arterial blood pressure monitoring.
Who may be able to join
- ASA I-IV,
- Scheduled for elective complex spinal surgery or cranial procedures under general anesthesia
Who cannot join
- congenital heart disease
- requirement for emergency surgery
- pre-existing peripheral circulatory disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anemia (Diagnosis)
- Being tested
- Masimo Radical-7® Pulse CO-Oximeter
- Medical subject headings
- Anemia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7® Pulse CO-OximeterDevice
Continuous non-invasive measurement of total hemoglobin (SpHb) using a pulse co-oximetry sensor during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Neurosurgery Patients | Pediatric patients undergoing neurosurgical procedures requiring invasive arterial pressure monitoring and hemoglobin measurement Receives: Device: Masimo Radical-7® Pulse CO-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement and Correlation between Non-invasive Hemoglobin (SpHb) and Invasive Arterial Hemoglobin (Hb) levels.
Measured: Intraoperative period (from induction of anesthesia to extubation, approximately 2-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Dec 2024
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FUNDA ARUN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352033
- Sponsor's protocol ID
- F6
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pulse Co-Oximetry a Reliable Alternative to Invasive Hemoglobin Measurement in Pediatric Neurosurgical Procedures?
- ClinicalTrials.gov ID
- NCT07352033
- Acronym / sponsor ID
- F6
- Conditions
- Anemia (Diagnosis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Neurosurgery Patients | – | Device: Masimo Radical-7® Pulse CO-OximeterPediatric patients undergoing neurosurgical procedures requiring invasive arterial pressure monitoring and hemoglobin measurement |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients admitted to the Department of Neurosurgery for elective surgery requiring general anesthesia and invasive arterial blood pressure monitoring.
Key inclusion criteria (2 listed)
- ASA I-IV,
- Scheduled for elective complex spinal surgery or cranial procedures under general anesthesia
Key exclusion criteria (3 listed)
- congenital heart disease
- requirement for emergency surgery
- pre-existing peripheral circulatory disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo Radical-7® Pulse CO-OximeterContinuous non-invasive measurement of total hemoglobin (SpHb) using a pulse co-oximetry sensor during the surgery. | Device | Pediatric Neurosurgery Patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia (Diagnosis), run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.