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
Qualifiers
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 design
Treatments tested in this trial
- MostCare (PRAM)
- Near-Infrared Spectroscopy (NIRS)
- Arterial Blood Gas with Lactate