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

NCT06263075 | Recruiting

• 2 other identifiers: 717/2023/Oss/AOUBo6822
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniosynostoses; Hypovolemia; Hemorrhage; Hemodynamic Instability

Keywords

Monitoring Physiologic; Monitoring Intraoperative

Outcome Measures

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.

  Entire duration of surgery

Secondary Outcomes (5)

• Evaluation of changes in volemic status

  during the surgery

• Evaluation of changes in volemic status

  during the surgery

• Evaluation of changes in systemic vascular resistance

  during the surgery

• Evaluation of changes in cardiac function

  during the surgery

• Evaluation of changes in cardiac function

  during the surgery

Study Arms (1)

Infants undergoing craniosynostosis corrective surgery

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

Interventions

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.

Infants undergoing craniosynostosis corrective surgery

Eligibility Criteria

• Age: 3 Months - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU of Bologna Policlinico Sant'Orsola

Bologna, BO, 40138, Italy

RECRUITING

Related Publications (6)

• Singh Y, Villaescusa JU, da Cruz EM, Tibby SM, Bottari G, Saxena R, Guillen M, Herce JL, Di Nardo M, Cecchetti C, Brierley J, de Boode W, Lemson J. Recommendations for hemodynamic monitoring for critically ill children-expert consensus statement issued by the cardiovascular dynamics section of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). Crit Care. 2020 Oct 22;24(1):620. doi: 10.1186/s13054-020-03326-2.

  PMID: 33092621 RESULT

• Calabrese S, Angileri S, Paolicchi O, Mancinelli P, Colosimo D, Ricci Z. Noninvasive vs. invasive arterial pressure during pediatric non cardiac surgery. Minerva Anestesiol. 2023 Sep;89(9):841-842. doi: 10.23736/S0375-9393.23.17338-X. Epub 2023 May 9. No abstract available.

  PMID: 37158631 RESULT

• 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.

  PMID: 27606930 RESULT

• 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.

  PMID: 24491036 RESULT

• 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.

  PMID: 21897172 RESULT

• 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.

  PMID: 33563386 RESULT

MeSH Terms

Conditions

Craniosynostoses; Hypovolemia; Hemorrhage

Interventions

Monitoring, Intraoperative

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative

Study Officials

• Maria Cristina Mondardini, MD

  IRCCS AOU of Bologna Policlinico Sant'Orsola

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Mondardini, MD

CONTACT

051 2143650; mariacristina.mondardini@aosp.bo.it

Fabio Caramelli, MD

CONTACT

fabio.caramelli@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 16, 2024
• Study Start: December 13, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)