An observational study in Craniosynostoses, Hypovolemia and Hemorrhage, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 3 Months to 8 Months. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
During major surgery under general anesthesia, the risk of hemodynamic instability and organ hypoperfusion resulting from depth of anesthesia, bleeding, or neurovegetative stimulation is high. In the pediatric age, it is essential to ensure adequate cerebral perfusion to preserve neurological function. Even more in younger age groups, given the limited knowledge of the safe boundaries of blood pressure and cerebral autoregulation, sufficient to ensure adequate cerebral perfusion. Traditional instrumental monitoring is clinically helpful but limited in specificity and accuracy. Instead, advanced hemodynamic monitoring techniques can allow early detection of changes in volemia and cardiac inotropism. The Pressure Recording Analytical Method (PRAM), installed in the monitor MostCare® (VYGON), analyzes the area under the curve of arterial blood pressure, beat by beat, to evaluate the dynamic impedance of the cardiovascular system. It estimates several parameters, including stroke volume and cardiac output, the preload by stroke volume variation and pulse pressure variation, the afterload by the systemic vascular resistances, and the arterial telesystolic elastance. Previous studies conducted on the pediatric population have demonstrated the applicability and reliability of MostCare® on young patients.
Craniosynostosis is an abnormal early fusion of cranial sutures. Physiological growth of the brain and impeded adaptation of the cranium will result in progressively increased intracranial pressure, dysmorphisms, delays, and impairment in neurodevelopment. Surgery is the core option for treatment, and the prognosis improves when performed soon, at 3-4 months of age or in the immediately following months. Hemodynamic changes resulting from deep anesthesia, bleeding, venous gas embolism, obstruction to cerebral venous outflow from an extreme head-bending position, and cerebrospinal fluid leakage after rupture of the dura may occur during the operation.
The objectives of the study are to describe and analyze the dynamic cardiovascular variables concurrently measured by MostCare® and other standardized monitors to capture events occurring in infants during corrective craniosynostosis surgery.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's planned enrollment of 30 is below the median of 43 across 26 observational studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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Consecutive infants aged 3 to 8 months with craniosynostosis admitted to the operating room of IRCCS AOU of Bologna Polyclinic Sant'Orsola to undergo corrective surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Hemodynamic events occurring during surgery
Number of hemodynamic events during surgery. Hemodynamic events are defined as a reduction or increase of 20% from the baseline of parameters measured by monitors. The baseline value per individual participant corresponds to the value recorded for each parameter at the time of starting monitoring.
Time frame: Entire duration of surgery
Evaluation of changes in volemic status
Absolute values and variations of Pulse Pressure Variation (PPV) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).
Time frame: during the surgery
Evaluation of changes in volemic status
Absolute values and variations of Stroke Volume Variation (SVV) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).
Time frame: during the surgery
Evaluation of changes in systemic vascular resistance
Absolute values and variations of Systemic Vascular Resistance Index (SVRI) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).
Time frame: during the surgery
Evaluation of changes in cardiac function
Absolute values and variations of Cardiac output Index (CI) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).
Time frame: during the surgery
Evaluation of changes in cardiac function
Absolute values and variations of maximum pressure variation (dP/dt (max) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).
Time frame: during the surgery
Plan to share: No
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