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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Coarctation Surgery Group | Neonates and infants aged 0-3 months with body weight 2.5-3.5 kg undergoing surgical repair of aortic coarctation. Cardiac index (MostCare™/PRAM), cerebral and renal NIRS (INVOS™), and arterial lactate levels are recorded at four intraoperative time points under standard anesthesia protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bedia Mine Hanedan, MD | Contact | +905059269595 | bediaminech@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bedia Mine Hanedan, MD | Konya City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SBÜ Konya Şehir Hastanesi | Konya | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12085677 | Background | Viguera AC, Cohen LS, Baldessarini RJ, Nonacs R. Managing bipolar disorder during pregnancy: weighing the risks and benefits. Can J Psychiatry. 2002 Jun;47(5):426-36. doi: 10.1177/070674370204700503. | |
| 31582201 | Background | 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. |
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|
| 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. |
|
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| Arterial Blood Gas with Lactate | Procedure | Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring. |
|
| 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. | Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery) |
| 29435754 | Background | 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. |
| 26925510 | Background | 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.2016.02.001. Epub 2016 Feb 6. |
| 26001321 | Background | 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. |
| ID | Term |
|---|---|
| D001017 | Aortic Coarctation |
| D002303 | Cardiac Output, Low |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| D001784 | Blood Gas Analysis |
| D019344 | Lactic Acid |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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