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Can Perfusion Index and Cerebral Oxygen Saturation Trends Predict Low Cardiac Output in Pediatric Cardiovascular Surgeries

StatusNot Yet Recruiting
PhaseNot specified
Started2025-04-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 17, 2025 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-03-14
Study Status v1
Primary completion date2025-06-01→2025-08-01
Start date2025-01-01→2025-04-01
2025-01-03
Original filing
In this prospective, observational study, we aim to investigate whether routinely monitored Perfusion Index (PI) and cerebral oxygen saturation (NIRS) values in pediatric patients aged 0-6 undergoing congenital heart surgery are associated with Low Cardiac Output Syndrome. Pediatric patients aged 0-6 years undergoing congenital heart surgery will be followed primarily for Cerebral Near-Infrared Reflectance Spectroscopy, and Perfusion Index (PI) values both in the operating room during the operation, and in the Pediatric Cardiac Intensive Care Unit during the first 24 hours postoperatively. The patients with Low Cardiac Output Syndrome will be recorded, and the changes in Cerebral Near-Infrared Reflectance Spectroscopy, and Perfusion Index (PI) values will be evaluated to determine whether they can predict low cardiac output.
Trial Details
NCT Number NCT06759506
Lead Sponsor Bozyaka Training and Research Hospital
Collaborators: Basaksehir Cam & Sakura City Hospital
Conditions Perfusion Index and Cerebral NIRS Trends in Low Cardiac Output Syndrome
Enrollment 40 participants
Start Date 2025-04-01
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-17