About this trial
This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral/renal regional oxygen saturation measured by near-infrared spectroscopy (NIRS) and arterial lactate levels in neonates and infants (body weight 2.5-3.5 kg, age 0-3 months) undergoing surgical repair of aortic coarctation. Measurements will be recorded at four intraoperative time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery. No additional intervention beyond standard anesthesia and surgical care will be applied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates and infants planned for surgical repair of aortic coarctation
Body weight between 2.5 and 3.5 kg
Postnatal age between 0 and 3 months
Considered hemodynamically stable for anesthesia and surgery
Disqualifiers
Severe multiorgan dysfunction
Additional major congenital heart defect (e.g., Tetralogy of Fallot, Transposition of Great Arteries, Hypoplastic Left Heart Syndrome)
Surgery requiring cardiopulmonary bypass
Preoperative metabolic acidosis or sepsis
Trial population
Neonates and infants aged 0-3 months with body weight 2.5-3.5 kg diagnosed with aortic coarctation and scheduled for surgical repair at SBU Konya City Hospital, Konya, Turkey.
Trial design
Cohort
Prospective
Treatments tested in this trial
MostCare (PRAM)
DeviceReal-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.
Near-Infrared Spectroscopy (NIRS)
DeviceNon-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care.
Arterial Blood Gas with Lactate
Procedure/SurgeryArterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.
Treatment groups
Trial outcomes
Primary outcomes
Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c)
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) measured by MostCare™ (PRAM method) and cerebral regional oxygen saturation (rSO2c, %) measured by INVOS™ oximeter at four intraoperative time points.
Secondary outcomes
Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r)
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and renal regional oxygen saturation (rSO2r, %) at four intraoperative time points.
Correlation between PRAM-derived Cardiac Index and Arterial Lactate Level
Pearson or Spearman correlation coefficient between cardiac index (CI, L/min/m²) and arterial lactate level (mmol/L) at four intraoperative time points.
Sponsors and contacts
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