Evaluation of the Hemodynamic Variability During Craniosynostosis Surgery: a Comparison Between Traditional Hemodynamic Monitoring and Pressure Recording Analytic Method (CRASY-PRAM)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS AOU of Bologna Policlinico Sant'Orsola
RECRUITING
Bologna
Contact Information
Primary
Maria Cristina Mondardini, MD
mariacristina.mondardini@aosp.bo.it
051 2143650
Backup
Fabio Caramelli, MD
fabio.caramelli@aosp.bo.it
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2026-06
Participants
Target number of participants: 30
Treatments
Infants undergoing craniosynostosis corrective surgery
Infants aged 3 to 8 months with craniosynostosis admitted to the operating room of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero-Universitaria (AOU) of Bologna Polyclinic Sant'Orsola to undergo corrective surgery.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov