Pressure recording analytical method and bioreactance for stroke volume index monitoring during pediatric cardiac surgery.
Cristiana Garisto, Isabella Favia, Zaccaria Ricci...
https://pubmed.ncbi.nlm.nih.gov/24491036/Actively Recruiting
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-10-03
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are studying hemodynamic changes during corrective craniosynostosis surgery in infants aged 3 to 8 months. Craniosynostosis is a condition where the skull bones fuse too early, potentially leading to increased brain pressure and developmental delays. The study aims to better understand cardiovascular stability during surgery by comparing traditional monitoring methods with a new technology called the Pressure Recording Analytic Method PRAM. During surgery under general anesthesia, infants are monitored using standard devices alongside the MostCare system with PRAM technology. This advanced method continuously analyzes arterial blood pressure to estimate heart function and blood flow parameters. Data are collected every few minutes throughout the surgery to capture dynamic cardiovascular changes. Parents can expect their child to undergo usual anesthesiological care including fasting and pain management. Monitoring includes pulse oximetry, cerebral oxygen levels, and optional brain function tracking. The study closely observes blood volume, vascular resistance, and cardiac performance during surgery. Safety is maintained by experienced anesthesiologists and continuous data collection. Participation covers the surgery duration, with no additional long-term follow-up mentioned.
CONDITIONS
Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
M
Maria Cristina Mondardini, MD
F
Fabio Caramelli, MD
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery
Participants undergo corrective craniosynostosis surgery during which advanced hemodynamic monitoring is performed using traditional and new technology monitors to assess cardiovascular function and hemodynamic changes.
1 visit (in-person, day of surgery)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/33563386/IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor