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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-8
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Congenital or acquired cardiac disease

Preoperative cardiac dysfunction

Metabolic diseases

Gestational age at birth <30 weeks

Trial design

Treatments tested in this trial

  • Intraoperative monitoring

Treatment groups

30 Participants
are divided into 1 treatment group