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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intraoperative monitoring

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Infants undergoing craniosynostosis corrective surgery1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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