Monitoring blood flow during surgery for craniosynostosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates hemodynamic monitoring techniques during craniosynostosis surgery in infants aged 3 to 8 months. It compares traditional monitoring methods with advanced technologies to assess cardiovascular stability and detect changes in blood pressure, cardiac output, and blood volume. The study aims to improve understanding of hemodynamic profiles in pediatric patients and enhance the safety of anesthetic management during surgery. By utilizing the Pressure Recording Analytical Method (PRAM), the research seeks to provide more accurate and specific monitoring of hemodynamic status.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS AOU of Bologna Policlinico Sant'Orsola
  Bologna, Bo, Italy Recruiting

Study contacts

• Principal investigator: Maria Cristina Mondardini, MD — IRCCS AOU of Bologna Policlinico Sant'Orsola
• Study coordinator: Maria Cristina Mondardini, MD
• Email: mariacristina.mondardini@aosp.bo.it
• Phone: 051 2143650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.