NCT06263075 Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
| NCT ID | NCT06263075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Craniosynostoses |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-12-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated. Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses. This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements.
Eligibility Criteria
Inclusion Criteria: * Infants with craniosynostosis undergoing corrective surgery * Ages between 3 and 8 months * Physical status classification of the American Society of Anesthesiologists (ASA) \</= 2 * Consent obtained from the patients' parents/legal guardians Exclusion Criteria: * Congenital or acquired cardiac disease * Preoperative cardiac dysfunction * Metabolic diseases * Gestational age at birth \<30 weeks * Body weight less than 3 kg * Dislocation or malfunction of the arterial catheter * Malfunctioning of monitoring devices
Contact & Investigator
Maria Cristina Mondardini, MD
PRINCIPAL INVESTIGATOR
IRCCS AOU of Bologna Policlinico Sant'Orsola
Frequently Asked Questions
Who can join the NCT06263075 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 8 Months, studying Craniosynostoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06263075 currently recruiting?
Yes, NCT06263075 is actively recruiting participants. Contact the research team at mariacristina.mondardini@aosp.bo.it for enrollment information.
Where is the NCT06263075 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06263075 clinical trial?
NCT06263075 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Maria Cristina Mondardini, MD at IRCCS AOU of Bologna Policlinico Sant'Orsola. The trial plans to enroll 30 participants.