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临床试验/NCT07568431
NCT07568431尚未招募不适用

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

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
43
试验地点
1

研究概览

简要总结

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.

详细描述

Low cardiac output syndrome (LCOS) is a major determinant of postoperative morbidity and mortality in neonatal cardiac surgery, particularly in lesions affecting systemic circulation such as aortic coarctation. Reliable intraoperative assessment of cardiac output is therefore critical in this patient population.

The MostCare™ system uses the Pressure Recording Analytical Method (PRAM) to provide real-time, calibration-free cardiac index (CI) measurement derived solely from the arterial pressure waveform. Previous studies in infants have demonstrated good correlation between PRAM and echocardiography; however, data in neonates weighing less than 3.5 kg remain very limited.

Near-infrared spectroscopy (NIRS) allows non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2), serving as an early indicator of tissue oxygenation. Arterial lactate is a biochemical marker of cellular hypoperfusion and is strongly associated with postoperative outcomes.

In this study, CI (MostCare™), cerebral and renal NIRS (INVOS™ oximeter), and arterial lactate will be simultaneously recorded at four intraoperative time points in neonates and infants undergoing aortic coarctation repair. The primary aim is to assess the correlation between PRAM-derived CI and cerebral NIRS. Secondary aims include the correlation between CI and renal NIRS, and between CI and arterial lactate levels.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • Written informed consent obtained from legal guardians

排除标准

  • 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
  • Inability to obtain informed consent from legal guardians

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

BEDİA MİNE HANEDAN

Principal Investigator

Konya City Hospital

研究点 (1)

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