Non-invasive Intracranial Pressure Monitoring in Brain Tumor Patients

ConditionsBrain Neoplasm Intracranial Pressure Increase

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age21+

SponsorTanta University

About this trial

This research protocol focuses on the pre- and post-operative evaluation of ICP using non-invasive methods, particularly in the context of surgery for brain tumor removal. By utilizing ocular ultrasound to measure ONSD and ONSD/ETD ratios, this study hypothesizes that the utility of these parameters in monitoring ICP pre- and post-operative periods could be effective.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Adult patients (>21 years) undergoing brain tumor resection surgery.

Preoperative imaging-confirmed diagnosis of the tumor.

American Society of Anesthesiologists (ASA) physical status II to IV

Consent to participate in the study.

Disqualifiers

• Preexisting ocular conditions affecting the optic nerve or globe integrity, such as glaucoma, thyroid-associated ophthalmopathy, or other optic nerve diseases.

Combined ocular and optic nerve injuries at admission.

History of cranial trauma, prior neurosurgery, or lumbar puncture performed within 2 weeks before the measurement of optic nerve sheath diameter (ONSD).

History of subarachnoid hemorrhage (SAH).

Trial population

This is a prospective observational study that will be conducted on 60 adult patients aged more than 21 years with ASA physical status II or IV. These patients will be admitted for brain tumor resection surgery at Tanta University Hospitals undergoing brain tumor resection surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Ocular Sonography
Diagnostic test
The examination will employ an ultrasound machine with a linear probe. Patients will be positioned supine with their heads elevated at a 20-30° angle. They will be instructed to keep their eyes closed in a neutral position while suppressing voluntary eye movement.The transducer will be gently placed on the gel in the temporal region of the eyelid to avoid exerting pressure on the eye. Optic nerve sheath diameter will be measured 3 mm posterior to the optic nerve's tip, with electronic calipers used to measure the values. ONSD will be defined as the distance within the dura mater, and ETD will be measured across the maximal transverse diameter of the eyeball, from one side of the retina behind the lens to the other. Measurements will be taken in both coronal and sagittal planes by positioning the probe perpendicular (90°) to the coronal plane, ensuring optimal alignment of the optic nerve with the probe.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

optic nerve sheath diameter dynamics

the measuremnt of optic nerve sheath diameter and optic nerve sheath diameter to transverse eyeball diamter ratio

Time frame

before (in the preoperative holding area) and after the surgery (immediate, 1,2, 4, 6, and 12 hr in ICU).

Sponsors and contacts

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

Tanta University

Lead sponsor

Source ClinicalTrials.gov

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