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

28. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

43

Kontakter og lokationer

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Studiekontakt

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Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: 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.
Andre navne:
  • Pressure Recording Analytical Method
Enhed: 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.
Andre navne:
  • 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r)
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

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Sponsor

Konya City Hospital

Efterforskere

  • Ledende efterforsker: Bedia Mine Hanedan, MD, Konya City Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 828-828-17

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