JUgular Gating for Upright Level Adjustment and Targeted Enhancement of Cerebral Perfusion (JUGULATE)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: David ROURE
- Numéro de téléphone: +33 05 57 87 02 01
- E-mail: david.roure@chu-bordeaux.fr
Lieux d'étude
-
-
-
Bordeaux, France
- Bordeaux University Hospital
-
Contact:
- David ROURE
- Numéro de téléphone: +33 05 57 87 02 01
- E-mail: david.roure@chu-bordeaux.fr
-
Chercheur principal:
- Grégoire CANE, Dr
-
Sous-enquêteur:
- David ROURE
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Experimental group
Patients ≥ 18 years old hospitalized in the neurocritical care unit or the trauma unit in clinically stable condition allowing transient positional changes
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intracranial pressure
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cerebral perfusion pressure at 30° and at angle α (1)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.
Délai: At inclusion (Day 0)
|
Intra-subject statistical analysis for modeling the relationship between angle and intracranial pressure
|
At inclusion (Day 0)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Grégoire CANE, Dr, University Hospital, Bordeaux
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CHUBX 2026/011
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .