Determination of Blood Pressure Limit of Cerebral Autoregulation During Non-cardiac Surgery in Preterm Infants, Neonates and Term Infants: a Prospective Observational Study Using Near-infrared Spectroscopy Monitoring
This prospective observational study aims to determine the blood pressure range in which cerebral autoregulation is maintained in preterm neonates, preterm infants, term neonates, and term infants undergoing non-cardiac surgery under general anesthesia. Cerebral autoregulation will be assessed using the cerebral oximetry index, calculated from mean arterial pressure and regional cerebral oxygen saturation measured by near-infrared spectroscopy.
A total of 160 patients, 40 in each age group, will be enrolled. The lower limit of autoregulation, optimal mean arterial pressure, and upper limit of autoregulation will be estimated for each patient and compared across age groups. The results may help support age-specific intraoperative blood pressure management in vulnerable pediatric patients.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Seoul, Sydkorea
- Seoul National University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Pediatric patients undergoing non-cardiac surgery under general anesthesia Expected duration of anesthesia of 60 minutes or longer
Patients who meet one of the following age criteria:
Preterm neonates: born at <37 weeks of gestation and ≤1 month of postnatal age Preterm infants: born at <37 weeks of gestation and 1-12 months of postnatal age Term neonates: born at ≥37 weeks of gestation and ≤1 month of postnatal age Term infants: born at ≥37 weeks of gestation and 1-12 months of postnatal age Written informed consent obtained from a parent or legal guardian
Exclusion Criteria:
- Presence of residual congenital heart disease
- Undergoing cardiac surgery
- Undergoing neurosurgery
- Presence of severe brain malformation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Preterm neonates
born before 37 weeks' gestation, ≤1 month of age
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Preterm infants
born before 37 weeks' gestation, 1-12 months of age
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Term neonates
born at ≥37 weeks' gestation, ≤1 month of age
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Term infants
born at ≥37 weeks' gestation, 1-12 months of age
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Blood pressure limits of cerebral autoregulation
Tidsramme: From the start of cerebral oxygen saturation monitoring after arrival in the operating room until the end of general anesthesia, approximately 1 to 6 hours.
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From the start of cerebral oxygen saturation monitoring after arrival in the operating room until the end of general anesthesia, approximately 1 to 6 hours.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- H2602-079-1717
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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