- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07665606
JUgular Gating for Upright Level Adjustment and Targeted Enhancement of Cerebral Perfusion (JUGULATE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: David ROURE
- Phone Number: +33 05 57 87 02 01
- Email: david.roure@chu-bordeaux.fr
Study Locations
-
-
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Bordeaux, France
- Bordeaux University Hospital
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Contact:
- David ROURE
- Phone Number: +33 05 57 87 02 01
- Email: david.roure@chu-bordeaux.fr
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Principal Investigator:
- Grégoire CANE, Dr
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Sub-Investigator:
- David ROURE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intracranial pressure
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebral perfusion pressure at 30° and at angle α (1)
Time Frame: 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)
Time Frame: 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.
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At inclusion (day 0)
|
|
Cerebral perfusion pressure at 30° and at angle α (3)
Time Frame: 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)
|
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Intracranial pressure
Time Frame: At inclusion (day 0)
|
Ultrasound measurement using a vascular probe at angles of 0°, 10°, 20°, 30°, and the calculated angle α.
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At inclusion (day 0)
|
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Variation in internal jugular vein luminal cross-sectional area.
Time Frame: At inclusion (Day 0)
|
Intra-subject statistical analysis for modeling the relationship between angle and intracranial pressure
|
At inclusion (Day 0)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Grégoire CANE, Dr, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHUBX 2026/011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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