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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MostCare (PRAM)

    Device

    Real-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)

    Device

    Non-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/Surgery

    Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: Aortic Coarctation Surgery Group3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)

Secondary outcomes

1

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.

Time frame
Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)
2

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.

Time frame
Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)

Other outcomes

Sponsors and contacts

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