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

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
CraniosynostosesHypovolemiaHemorrhageHemodynamic Instability
Interventions
PROCEDURE

Intraoperative monitoring

"ANESTHESIOLOGICAL MANAGEMENT accords to usual practice. Participants underwent preoperative fasting (3 h for breast milk, 4 h for formula milk, and 1 h for clear liquids), no premedication, induction and maintenance by sevoflurane, fentanyl boluses for analgesia, mechanical ventilation (PEEP 4 cm H2O, target tidal volume 6-8 ml/Kg, end tidal CO2 32-40 mmHg), 10 ml/Kg/h of intraoperative fluids. Scalp block is performed before surgery.~MONITORING DURING SURGERY: monitor devices routinely used are connected to the participant: Dräger Infinity Delta XL®, Masimo® for pulse oximetry (Rainbow SET), regional cerebral oximetry (O3TM), and (optional) brain function monitoring (Masimo® SedLine). Arterial blood gas test is sampled at the anesthesiologist's discretion. After the artery catheterization, the MostCare® system is simultaneously connected to the patient monitoring devices. Data are collected every 3 minutes, 6 minutes for the noninvasive blood pressure measurement."

Trial Locations (1)

40138

RECRUITING

IRCCS AOU of Bologna Policlinico Sant'Orsola, Bologna

All Listed Sponsors
lead

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER