Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery (MostCare-Ped)

April 28, 2026 updated by: BEDİA MİNE HANEDAN, Konya City Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Real-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.
Other Names:
  • Pressure Recording Analytical Method
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.
Other Names:
  • INVOS Oximeter
Procedure: Arterial Blood Gas with Lactate
Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Investigators

  • Principal Investigator: Bedia Mine Hanedan, MD, Konya City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 828-828-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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