Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MostCare (PRAM), Near-Infrared Spectroscopy (NIRS), Arterial Blood Gas with Lactate.
- Who it may be relevant to
- Registry conditions: Aortic Coarctation, Cardiac Output, Low. Basic parameters: up to 3 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c) [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 outcome measures (2)
- Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r) [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)]
- Correlation between PRAM-derived Cardiac Index and Arterial Lactate Level [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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- SBÜ Konya Şehir Hastanesi — Konya
Publications
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- Zaleski KL, Kussman BD. Near-Infrared Spectroscopy in Pediatric Congenital Heart Disease. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):489-500. doi: 10.1053/j.jvca.2019.08.048. Epub 2019 Sep 3. PMID 31582201
- Francis NK, Curtis NJ, Conti JA, Foster JD, Bonjer HJ, Hanna GB; EAES committees. EAES classification of intraoperative adverse events in laparoscopic surgery. Surg Endosc. 2018 Sep;32(9):3822-3829. doi: 10.1007/s00464-018-6108-1. Epub 2018 Feb 12. PMID 29435754
- Itzcovich T, Xi Z, Martinetto H, Chrem-Mendez P, Russo MJ, de Ambrosi B, Uchitel OD, Nogues M, Silva E, Rojas G, Bagnatti P, Amengual A, Campos J, Rogaeva E, St George-Hyslop P, Allegri R, Sevlever G, Surace EI. Analysis of C9orf72 in patients with frontotemporal dementia and amyotrophic lateral sclerosis from Argentina. Neurobiol Aging. 2016 Apr;40:192.e13-192.e15. doi: 10.1016/j.neurobiolaging.2 PMID 26925510
- Galyfos G, Sigala F, Aggeli K, Filis K. Re: 'long-term results of a randomized controlled trial analyzing the role of systematic pre-operative coronary angiography before elective carotid endarterectomy in patients with asymptomatic coronary artery disease'. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):263-4. doi: 10.1016/j.ejvs.2015.04.020. Epub 2015 May 20. No abstract available. PMID 26001321
Identifiers
NCT: NCT07568431 · 828-828-17