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

NCT07568431 | Not Yet Recruiting

• 1 other identifier: 828-828-17
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Coarctation; Cardiac Output, Low

Keywords

PRAM; Near-Infrared Spectroscopy; Cardiac Index; Pediatric Cardiac Surgery; Lactate; Aortic Coarctation

Outcome Measures

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.

  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 (2)

• Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r)

  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

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

Study Arms (1)

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.

Device: MostCare (PRAM); Device: Near-Infrared Spectroscopy (NIRS); Procedure: Arterial Blood Gas with Lactate

Interventions

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.

Also known as: INVOS Oximeter

Aortic Coarctation Surgery Group

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.

Also known as: Pressure Recording Analytical Method

Aortic Coarctation Surgery Group

Arterial Blood Gas with Lactate PROCEDURE

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

Aortic Coarctation Surgery Group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

SBÜ Konya Şehir Hastanesi

Konya, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 12085677 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.

  PMID: 31582201 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.

  PMID: 29435754 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.

  PMID: 26925510 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.

  PMID: 26001321 BACKGROUND

MeSH Terms

Conditions

Aortic Coarctation; Cardiac Output, Low

Interventions

Spectroscopy, Near-Infrared; Blood Gas Analysis; Lactic Acid

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Bedia Mine Hanedan, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bedia Mine Hanedan, MD

CONTACT

+905059269595; bediaminech@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)