Monitoring blood flow during surgery for craniosynostosis
Evaluation of the Hemodynamic Variability During Craniosynostosis Surgery: a Comparison Between Traditional Hemodynamic Monitoring and Pressure Recording Analytic Method (CRASY-PRAM)
This study is testing new ways to monitor blood flow during surgery for craniosynostosis in infants to see if they can make the procedure safer and more effective.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 3 Months to 8 Months |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06263075 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants aged 3 to 8 months with craniosynostosis undergoing corrective surgery.
Not a fit: Patients with congenital or acquired cardiac diseases, preoperative cardiac dysfunction, or metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that enhance patient safety and outcomes during craniosynostosis surgeries.
How similar studies have performed: Previous studies have shown the applicability and reliability of advanced hemodynamic monitoring techniques in pediatric populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, BO
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.