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NCT Number: NCT06263075

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

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.

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Key information

Age range

3 month–8 month

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU of Bologna Policlinico Sant'Orsola

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Andrea La Placa, MD

SUB_INVESTIGATOR

Barbara Lotito, MD

CONTACT

[email protected]

051 2141296 ext. +39

Fabio Caramelli, MD

SUB_INVESTIGATOR

Lorena Pasini, MD

SUB_INVESTIGATOR

Luigia Scudeller, MD

CONTACT

[email protected]

051 2141402 ext. +39

Rosario Ruga, Student

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative monitoring

Procedure

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.

Primary outcomes

  1. Hemodynamic events occurring during surgery

    Time frame: Entire duration of 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.

Secondary outcomes

  1. Evaluation of changes in volemic status

    Time frame: during the surgery

    Absolute values and variations of Pulse Pressure Variation (PPV) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).

  2. Evaluation of changes in volemic status

    Time frame: during the surgery

    Absolute values and variations of Stroke Volume Variation (SVV) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).

  3. Evaluation of changes in systemic vascular resistance

    Time frame: during the surgery

    Absolute values and variations of Systemic Vascular Resistance Index (SVRI) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).

  4. Evaluation of changes in cardiac function

    Time frame: during the surgery

    Absolute values and variations of Cardiac output Index (CI) from MostCare® every reduction of 20% from the baseline of invasive blood pressure (IBP).

  5. Evaluation of changes in cardiac function

    Time frame: during the surgery

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Caramelli, MD

CONTACT

[email protected]

Maria Cristina Mondardini, MD

CONTACT

[email protected]

051 2143650 ext. +39

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: CRASY-PRAM

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 16, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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