Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 3
SponsorKonya City Hospital

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

Treatment groups

43 Participants
are divided into 1 treatment group

Sponsors and collaborators