Actively Recruiting
Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-10-03
30
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS AOU of Bologna Policlinico Sant'Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
Research Team
M
Maria Cristina Mondardini, MD
CONTACT
F
Fabio Caramelli, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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