Intracranial PressureJUGULATENCT07665606
JUgular Gating for Upright Level Adjustment and Targeted Enhancement of Cerebral Perfusion
An observational study of Intracranial Pressure and Critical Care, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure, Critical Care
- What is being tested?
- Ultrasound assessment
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient hospitalized in the neurocritical care unit or the trauma unit
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Bordeaux university hospital
Bordeaux
David ROURE, 05 57 87 02 01 ext. +33, david.roure@chu-bordeaux.fr
Grégoire CANE, Dr
About this study
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.
Read the 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.
- Conditions
- Intracranial Pressure, Critical Care
- Being tested
- Ultrasound assessment
- Keywords
- Intracranial Pressure, jugular vein collapse, Critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients ≥ 18 years old hospitalized in the neurocritical care unit or the trauma unit in clinically stable condition allowing transient positional changes Receives: Procedure: Ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial pressure
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.
Measured: At inclusion (day 0)
Secondary outcomes (5)
Cerebral perfusion pressure at 30° and at angle α (1)
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.
Measured: At inclusion (day 0)
Cerebral perfusion pressure at 30° and at angle α (2)
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.
Measured: At inclusion (day 0)
Cerebral perfusion pressure at 30° and at angle α (3)
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.
Measured: At inclusion (day 0)
Intracranial pressure
Ultrasound measurement using a vascular probe at angles of 0°, 10°, 20°, 30°, and the calculated angle α.
Measured: At inclusion (day 0)
Variation in internal jugular vein luminal cross-sectional area.
Intra-subject statistical analysis for modeling the relationship between angle and intracranial pressure
Measured: At inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire CANE, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665606
- Sponsor's protocol ID
- CHUBX 2026/011
- Acronym
- JUGULATE
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUgular Gating for Upright Level Adjustment and Targeted Enhancement of Cerebral Perfusion
- ClinicalTrials.gov ID
- NCT07665606
- Acronym / sponsor ID
- JUGULATE / CHUBX 2026/011
- Conditions
- Intracranial Pressure, Critical Care
- Keywords
- Intracranial Pressure, jugular vein collapse, Critical care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Procedure: Ultrasound assessmentPatients ≥ 18 years old hospitalized in the neurocritical care unit or the trauma unit in clinically stable condition allowing transient positional changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in the neurocritical care unit or the trauma unit
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound assessmentAfter 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. | Procedure or surgery | Experimental group |
Primary outcome
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.
5 secondary outcomes
Cerebral perfusion pressure at 30° and at angle α (1)
Time frame: At inclusion (day 0)
Cerebral perfusion pressure at 30° and at angle α (2)
Time frame: At inclusion (day 0)
Cerebral perfusion pressure at 30° and at angle α (3)
Time frame: At inclusion (day 0)
Intracranial pressure
Time frame: At inclusion (day 0)
Variation in internal jugular vein luminal cross-sectional area.
Time frame: At inclusion (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grégoire CANE, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure and Critical Care, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David ROURE (05 57 87 02 01 ext. +33, david.roure@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial pressure (time frame: At inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.