Fingertip sensor may help surgeons manage bleeding in infant skull operations
NCT ID NCT07657598
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a simple, non-invasive fingertip sensor (called pleth variability index, or PVI) can help doctors track blood pressure and fluid needs during skull surgery in children aged 0 to 6 years with craniosynostosis. The researchers will compare PVI readings with standard vital signs and note any bleeding or transfusion needs. The goal is to see if this sensor provides useful extra information to guide care during surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better, safer ways to monitor and manage blood pressure and fluid balance during pediatric skull surgeries.
- What could go wrong
- This is a small observational study, so it can only show associations, not cause and effect. The results may not apply to all children or other types of surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pediatric patients aged 0-6 years who are scheduled to undergo craniosynostosis surgery at Başakşehir Çam and Sakura City Hospital will constitute the study population.
- Ages
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Up to 6 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pediatric patients aged 0 to 6 years * Patients scheduled to undergo craniosynostosis surgery * American Society of Anesthesiologists physical status I, II or III * Written informed consent obtained from the parent or legal guardian Exclusion Criteria: * Patients older than 6 years * American Society of Anesthesiologists physical status IV * Inappropriate preoperative fasting status * History of significant cardiac, pulmonary or renal disease * Patients operated at another institution and subsequently transferred to the study center * Patients with peripheral circulatory impairment * Withdrawal of consent by the parent or legal guardian
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Basaksehir Cam and Sakura City Hospital
RECRUITINGIstanbul, Basaksehir, 34480, Turkey (Türkiye)
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