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JUgular Gating for Upright Level Adjustment and Targeted Enhancement of Cerebral Perfusion (JUGULATE)

18. juni 2026 oppdatert av: University Hospital, Bordeaux
Investigators aim to demonstrate that the evolution of intracranial pressure (ICP) is nonlinear and may be influenced by jugular vein collapse. This collapse is estimated to occur at the angle where the hydrostatic pressure of the blood column matches the central venous pressure, and it can be assessed using ultrasonography. This approach allows for the determination of an individualized tilt angle, optimizing cerebral perfusion pressure without compromising venous drainage.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cerebral venous drainage is a major determinant of intracranial pressure (ICP), yet the relationship between trunk inclination and ICP remains incompletely understood. Physiological data in healthy subject suggest that venous outflow may behave nonlinearly, with a threshold angle beyond which further elevation only modestly improves drainage while taking the risk of increasingly compromising cerebral perfusion pressure (CPP). The internal jugular vein (IJV) is the primary conduit for upright cerebral venous return; its collapse was estimated in healthy subjects to occurs when jugular hydrostatic pressure exceeds central venous pressure. Understanding the precise angle at which IJV collapse occurs may allow safer patient positioning strategies in critical care. Doppler ultrasonography, ICP measurements and cerebral perfusion pressure provide complementary data on this physiological breakpoint. Accurate characterization of this nonlinearity may improve cerebral perfusion management and reduce secondary brain injury.

After the routine nursing care, during patient repositioning to 30 ° assessments are performed at 0, 10° 20° 30°, and at a calculated threshold angle α. At each angle ICP, CPP and Ultrasound assessment of cerebral blood flow velocities and IJV cross-sectional area at three cervical levels are recorded.

Physiological parameters including arterial blood pressure, ICP, and cerebral perfusion pressure are recorded at each angle. Doppler ultrasonography of the middle cerebral artery is performed for flow assessment. Ventilation parameters, sedation, and vasopressor support are maintained constant. Safety criteria for immediate cessation of the procedure includes ICP >20 mmHg, CPP <60 mmHg, or oxygen desaturation, the same criteria that would have stoped the routine nursing care. Data are analyzed to characterize the nonlinear relationship between trunk angle and cerebral venous outflow, with particular focus on the collapse threshold α.

Studietype

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
      • Bordeaux, Frankrike
        • Bordeaux University Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Grégoire CANE, Dr
        • Underetterforsker:
          • David ROURE

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patient hospitalized in the neurocritical care unit or the trauma unit

Beskrivelse

Inclusion Criteria:

  • Patients ≥ 18 years old
  • Hospitalized in the neurocritical care unit or the trauma unit
  • Scheduled for nursing care requiring a supine position.
  • Arterial catheter allowing continuous measurement of mean arterial pressure.
  • Central venous catheter for continuous measurement of central venous pressure.
  • External ventricular drain or intracranial pressure sensor for intracranial pressure monitoring.
  • Bed with controlled inclination capability.
  • Clinically stable condition allowing transient positional changes (as judged by the clinician).
  • Not included, or planned to be included in another trial.

Exclusion Criteria:

  • Contraindication to trunk mobilization.
  • Being a minor or placed under supervision.
  • Hemodynamic or respiratory instability.
  • Uncontrolled intracranial hypertension, refractory arterial hypertension, or severe dysautonomia.
  • Pregnancy or breastfeeding.
  • Refusal to participate in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Experimental group
Patients ≥ 18 years old hospitalized in the neurocritical care unit or the trauma unit in clinically stable condition allowing transient positional changes
Fremgangsmåte: Ultrasound assessment
After the routine nursing care, during patient repositioning to 30 ° assessments are performed at 0, 10° 20° 30°, and at a calculated threshold angle α. At each angle intracranial pressure , cerebral perfusion pressure and ultrasound assessment of cerebral blood flow velocities and internal jugular vein cross-sectional area at three cervical levels are recorded.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intracranial pressure
Tidsramme: At inclusion (day 0)
After the routine nursing care, during patient repositioning to 30 ° assessments are performed at 0, 10° 20° 30°, and at a calculated threshold angle α. At each angle intracranial pressure is recorded.
At inclusion (day 0)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cerebral perfusion pressure at 30° and at angle α (1)
Tidsramme: At inclusion (day 0)
Comparison of Cerebral perfusion pressure values based on mean arterial pressure measured at the tragus and intracranial pressure obtained via transcranial Doppler using a cardiac probe at the M1 segment of the ipsilateral middle sylvian artery corresponding to the jugular vein under study.
At inclusion (day 0)
Cerebral perfusion pressure at 30° and at angle α (2)
Tidsramme: At inclusion (day 0)
Comparison of Cerebral perfusion pressure values based on diastolic, systolic, and mean blood flow velocities obtained via transcranial Doppler using a cardiac probe at the M1 segment of the ipsilateral middle sylvian artery corresponding to the jugular vein under study.
At inclusion (day 0)
Cerebral perfusion pressure at 30° and at angle α (3)
Tidsramme: At inclusion (day 0)
Comparison of Cerebral perfusion pressure values based on pulsatility index obtained via transcranial Doppler using a cardiac probe at the M1 segment of the ipsilateral middle sylvian artery corresponding to the jugular vein under study.
At inclusion (day 0)
Intracranial pressure
Tidsramme: At inclusion (day 0)
Ultrasound measurement using a vascular probe at angles of 0°, 10°, 20°, 30°, and the calculated angle α.
At inclusion (day 0)
Variation in internal jugular vein luminal cross-sectional area.
Tidsramme: At inclusion (Day 0)
Intra-subject statistical analysis for modeling the relationship between angle and intracranial pressure
At inclusion (Day 0)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Bordeaux

Etterforskere

  • Hovedetterforsker: Grégoire CANE, Dr, University Hospital, Bordeaux

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

31. mars 2027

Datoer for studieregistrering

Først innsendt

4. juni 2026

Først innsendt som oppfylte QC-kriteriene

18. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CHUBX 2026/011

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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