Clinical trial NCT06263075: Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Official title: Evaluation of the Hemodynamic Variability During Craniosynostosis Surgery: a Comparison Between Traditional Hemodynamic Monitoring and Pressure Recording Analytic Method (CRASY-PRAM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Craniosynostoses
Hypovolemia
Hemorrhage
Hemodynamic Instability
Keywords: Monitoring Physiologic
Monitoring Intraoperative
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Hemodynamic events occurring during surgery
timeFrame: Entire duration of surgery
Secondary outcomes:
measure: Evaluation of changes in volemic status
timeFrame: during the surgery
measure: Evaluation of changes in volemic status
timeFrame: during the surgery
measure: Evaluation of changes in systemic vascular resistance
timeFrame: during the surgery
measure: Evaluation of changes in cardiac function
timeFrame: during the surgery
measure: Evaluation of changes in cardiac function
timeFrame: during the surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS AOU of Bologna Policlinico Sant'Orsola
state: BO
Study officials:
affiliation: IRCCS AOU of Bologna Policlinico Sant'Orsola
name: Maria Cristina Mondardini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: de Graaff JC, Pasma W, van Buuren S, Duijghuisen JJ, Nafiu OO, Kheterpal S, van Klei WA. Reference Values for Noninvasive Blood Pressure in Children during Anesthesia: A Multicentered Retrospective Observational Cohort Study. Anesthesiology. 2016 Nov;125(5):904-913. doi: 10.1097/ALN.0000000000001310.
citation: Garisto C, Favia I, Ricci Z, Romagnoli S, Haiberger R, Polito A, Cogo P. Pressure recording analytical method and bioreactance for stroke volume index monitoring during pediatric cardiac surgery. Paediatr Anaesth. 2015 Feb;25(2):143-9. doi: 10.1111/pan.12360. Epub 2014 Feb 3.
citation: Ricci Z, Pilati M, Favia I, Garisto C, Rossi E, Romagnoli S. Hemodynamic monitoring by pulse contour analysis in critically ill children with congenital heart disease. Pediatr Crit Care Med. 2011 Sep;12(5):608-9; author reply 609-10. doi: 10.1097/PCC.0b013e318219182b. No abstract available.
citation: Meier N. Anesthetic Considerations for Pediatric Craniofacial Surgery. Anesthesiol Clin. 2021 Mar;39(1):53-70. doi: 10.1016/j.anclin.2020.10.002. Epub 2021 Jan 12.