An observational study in Congenital Heart Disease, Pediatric Open Heart Surgery and Delirium - Postoperative, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Universitas Indonesia · Observational
The goal of this observational study is to examine the relationship between intraoperative cerebral blood flow and perfusion with postoperative delirium in pediatric patients undergoing open-heart surgery.
The main questions it aims to answer are:
Is there a correlation between changes in cerebral blood flow measured by Transcranial Color-Coded Duplex (TCCD) and changes in cerebral perfusion measured by Near-Infrared Spectroscopy (NIRS) during open-heart surgery in pediatric patients? Is there a correlation between reduced cerebral blood flow measured by TCCD and the occurrence of postoperative delirium in pediatric open-heart surgery patients? Is there a correlation between changes in cerebral perfusion measured by NIRS and the occurrence of postoperative delirium in pediatric open-heart surgery patients?
Pediatric patients undergoing open-heart surgery with cardiopulmonary bypass at Cipto Mangunkusumo Hospital (RSCM) will undergo intraoperative cerebral monitoring using TCCD and NIRS. Following surgery, participants will be assessed for delirium during their postoperative ICU stay using the Indonesian version of the Cornell Assessment of Pediatric Delirium (i-CAPD), a validated pediatric delirium screening tool adapted for Indonesian clinical settings.
Postoperative delirium is a serious neurological complication following pediatric open-heart surgery, associated with prolonged ICU stay, increased morbidity, and adverse neurodevelopmental outcomes. Despite its clinical significance, the underlying cerebrovascular mechanisms contributing to delirium in this population remain incompletely understood.
Cardiopulmonary bypass (CPB) during open-heart surgery exposes the pediatric brain to significant hemodynamic alterations, including non-pulsatile flow, hypothermia, hemodilution, and microemboli. These factors may impair cerebral autoregulation and reduce cerebral oxygen delivery, potentially contributing to neurological injury and subsequent delirium.
This study employs two complementary neuromonitoring modalities:
Transcranial Color-Coded Duplex (TCCD) will be used to measure intraoperative cerebral blood flow velocity in the middle cerebral artery (MCA), including mean flow velocity (MFV). Changes in these parameters reflect alterations in flow dynamics during CPB.
Near-Infrared Spectroscopy (NIRS) will be used to continuously monitor regional cerebral oxygen saturation (rSO₂) throughout the intraoperative period. Significant desaturation events, defined as a decrease in rSO₂ of more than 20% from baseline or an absolute value below 40%, will be recorded.
Delirium assessment will be performed postoperatively in the pediatric cardiac ICU using the i-CAPD (Indonesian version of the Cornell Assessment of Pediatric Delirium) at regular intervals at 24, 48 and 72 hours after RAAS score ≥-2. The i-CAPD has been validated for use in Indonesian pediatric populations and is applicable across all age groups and developmental stages.
Correlation analyses will be performed between intraoperative TCCD and NIRS parameters and the occurrence and severity of postoperative delirium, adjusting for relevant perioperative covariates including age, diagnosis, CPB duration, aortic cross-clamp time, and hemodynamic parameters.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's enrollment of 42 is below the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Universitas Indonesia is the lead sponsor of 35 studies on the registry; 13 are open to participants now.
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Pediatric patients with congenital heart disease undergoing open-heart surgery with cardiopulmonary bypass.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients aged 1-18 years with congenital heart disease undergoing elective open-heart surgery with cardiopulmonary bypass at Cipto Mangunkusumo Hospital (RSCM), Jakarta, Indonesia. All participants will undergo intraoperative cerebral monitoring using TCCD and NIRS, and postoperative delirium assessment using the i-CAPD.
Postoperative delirium
Postoperative delirium will be assessed using the Indonesian version of the Cornell Assessment of Pediatric Delirium (i-CAPD). The i-CAPD is an 8-item observational tool completed by bedside nurses, evaluating eye contact, purposeful actions, awareness of surroundings, restlessness, inconsolability, and movement. A score of ≥9 indicates delirium. Assessment will be performed every 12 hours during the postoperative ICU stay, beginning upon admission to the pediatric cardiac ICU following surgery.
Time frame: 24, 48, 72 hours after RAAS score≥-2
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2026 to primary completion in Aug 2026, 4 months.
Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's 4 months is below that.
Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Universitas Indonesia