Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07568431

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

Sponsor: Konya City Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Correlation of Cardiac Index Measured by the Pressure Recording Analytical Method (PRAM) With Near-Infrared Spectroscopy (NIRS) and Arterial Lactate Levels in Neonates and Infants Undergoing Surgical Repair of Aortic Coarctation: A Prospective Observational Study

Key Details

Gender

All

Age Range

Any - 3 Months

Study Type

OBSERVATIONAL

Enrollment

43

Start Date

2026-05

Completion Date

2027-03

Last Updated

2026-05-05

Healthy Volunteers

No

Interventions

DEVICE

MostCare (PRAM)

Real-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.

DEVICE

Near-Infrared Spectroscopy (NIRS)

Non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care.

PROCEDURE

Arterial Blood Gas with Lactate

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

Locations (1)

SBÜ Konya Şehir Hastanesi

Konya, Turkey (Türkiye)