Actively Recruiting

Age: 3Months - 8Months
All Genders
ID06263075

Evaluation of Hemodynamic Changes During Craniosynostosis Surgery Comparing Traditional and Pressure Recording Analytic Method Monitoring

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-10-03

30

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying hemodynamic changes during corrective craniosynostosis surgery in infants aged 3 to 8 months. Craniosynostosis is a condition where the skull bones fuse too early, potentially leading to increased brain pressure and developmental delays. The study aims to better understand cardiovascular stability during surgery by comparing traditional monitoring methods with a new technology called the Pressure Recording Analytic Method (PRAM). During surgery under general anesthesia, infants are monitored using standard devices alongside the MostCare system with PRAM technology. This advanced method continuously analyzes arterial blood pressure to estimate heart function and blood flow parameters. Data are collected every few minutes throughout the surgery to capture dynamic cardiovascular changes. Parents can expect their child to undergo usual anesthesiological care including fasting and pain management. Monitoring includes pulse oximetry, cerebral oxygen levels, and optional brain function tracking. The study closely observes blood volume, vascular resistance, and cardiac performance during surgery. Safety is maintained by experienced anesthesiologists and continuous data collection. Participation covers the surgery duration, with no additional long-term follow-up mentioned.

CONDITIONS

Brief Title

Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)

Who Can Participate

Age: 3Months - 8Months
All Genders

Eligibility Criteria

Eligible

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) �3c= 2
  • Consent obtained from the patients' parents/legal guardians
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Duration of surgery

Participants undergo corrective craniosynostosis surgery during which advanced hemodynamic monitoring is performed using traditional and new technology monitors to assess cardiovascular function and hemodynamic changes.

1 visit (in-person, day of surgery)

Trial Site Locations

Total: 1 location

1

IRCCS AOU of Bologna Policlinico Sant'Orsola

Bologna, BO, Italy, 40138

Actively Recruiting

Loading map...

Research Team

M

Maria Cristina Mondardini, MD

F

Fabio Caramelli, MD

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

Similar Trials

A Phase III, Open Label, Randomized, Controlled Study of VBI...

Septic Shock

Actively Recruiting

6 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Recommendations for hemodynamic monitoring for critically ill children-expert consensus statement issued by the cardiovascular dynamics section of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC).

Yogen Singh, Javier Urbano Villaescusa, Eduardo M da Cruz...

https://pubmed.ncbi.nlm.nih.gov/33092621

Reference Values for Noninvasive Blood Pressure in Children during Anesthesia: A Multicentered Retrospective Observational Cohort Study.

Jurgen C de Graaff, Wietze Pasma, Stef van Buuren...

https://pubmed.ncbi.nlm.nih.gov/27606930

Pressure recording analytical method and bioreactance for stroke volume index monitoring during pediatric cardiac surgery.

Cristiana Garisto, Isabella Favia, Zaccaria Ricci...

https://pubmed.ncbi.nlm.nih.gov/24491036