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Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolated Periorbital Vein

ConditionsIndication for CSF Dynamic TestingIndication for CSF Infusion Test
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorUniversity of Freiburg

About this trial

Elevated intracranial pressure (ICP) occurs when pressure inside the skull rises above normal levels, potentially leading to brain damage or herniation. Monitoring ICP is critical for managing conditions like brain tumors, traumatic brain injury, and stroke. Current ICP monitoring methods are invasive and carry risks, including infection and brain damage. For less severe cases, lumbar puncture is a safer, less invasive alternative. This study explores the potential of a non-invasive method, using venous pressure near the eye, to estimate ICP. The goal is to assess whether the results from this non-invasive approach are similar to the invasive lumbar CSF pressure measurements.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Medical indication to perform routine craniospinal CSF dynamic testing according to standard operative procedures

Aged 18-95

Willing and able to provide valid signed informed consent

Disqualifiers

Patients with any known ongoing, or history of, abnormal CSF communication

Patients with any kind of prior intervention for CSF diversion

Patients with acute brain damage within the preceding 6 months

Patients with transdural surgery within the preceding 6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • venous occlusion pressure Measurement

    Device

    non-invasive venous occlusion pressure of a targeted periorbital vein is measured in parallel to clinical standard CSF dyanmic testing including standard CSF infusiontest

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Venous occlusion pressure measurementsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Venous occlusion pressure measurement (mmHg)

Mean venous occlusion pressure of one isolated target periorbital frontal vein of 6 consecutive measurements in mmHg (mask inflated) during routine infusion test in recumbent lateral position

Time frame
60 minutes
2

intracranial Pressure (ICP) in mmHg

Invasive lumbar intracranial pressure measurements in mmHg (mean over a 1-minute window aligned with start of venous occlusion measurements, in mmHg) during routine infusion test in recumbent lateral position

Time frame
60 minutes

Secondary outcomes

1

Measurement of venous occlusive pressure in mmHg

Measurement of venous occlusive pressure in mmHg at the predefined time-points throughout the dynamic CSF test.

Time frame
60 minutes
2

Measurement of average systolic ICP in mmHg

Measurement of average systolic ICP in mmHg at the predefined time-points throughout the dynamic CSF test.

Time frame
60 minutes
3

Measurement of average diastolic ICP in mmHg

Measurement of average diastolic ICP in mmHg at the predefined time-points throughout the dynamic CSF test.

Time frame
60 minutes
4

Relationship of venous occlusion pressure measured in mmHg compared to average ICP-Amplitude in mmHg

Relationship of venous occlusion pressure measured in mmHg compared to average ICP-Amplitude in mmHg at the predefined time-points throughout the invasive CSF infusion test.

Time frame
60 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Freiburg

Lead sponsor

Source ClinicalTrials.gov
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