NCT07665606

Brief 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 ultrasonography. This approach allows for the determination of an individualized tilt angle, optimizing cerebral perfusion pressure without compromising venous drainage.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 4, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

Intracranial Pressurejugular vein collapseCritical care

Outcome Measures

Primary Outcomes (1)

  • 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.

    At inclusion (day 0)

Secondary Outcomes (5)

  • Cerebral perfusion pressure at 30° and at angle α (1)

    At inclusion (day 0)

  • Cerebral perfusion pressure at 30° and at angle α (2)

    At inclusion (day 0)

  • Cerebral perfusion pressure at 30° and at angle α (3)

    At inclusion (day 0)

  • Intracranial pressure

    At inclusion (day 0)

  • Variation in internal jugular vein luminal cross-sectional area.

    At inclusion (Day 0)

Study Arms (1)

Experimental group

Patients ≥ 18 years old hospitalized in the neurocritical care unit or the trauma unit in clinically stable condition allowing transient positional changes

Procedure: Ultrasound assessment

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient hospitalized in the neurocritical care unit or the trauma unit

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux university hospital

Bordeaux, France

Location

Study Officials

  • Grégoire CANE, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 24, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Locations