Perioperative Evaluation of Intracranial Hypertension by Ultrasound Measurement of Variations in the Diameter of the Sheath of the Optic Nerve in the Excision of a Tumor or Biopsy Supratentorial Brain

NCT ID: NCT01864499

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Neurosurgery for supratentorial brain tumor is frequently associated with preoperative intracranial hypertension. The evaluation of intracranial pressure is available noninvasively by measuring the diameter of the optic nerve sheath ultrasound.

The evaluation of intracranial pressure by measuring the DNO in perioperative is not described in the literature. The investigators propose a pilot study to assess intracranial pressure perioperative surgery for supratentorial brain tumor. The investigators consider a diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal healthy adult unanesthetized is 5 mm.

The main objective of the study is to compare the mean change in diameter of the optic nerve between the postoperative and D2 between groups of patients undergoing resection of a brain tumor and patients undergoing biopsy brain tumor.

Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients is estimated according to the recruiting capabilities of neurosurgery for this type of patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control group: 20 patients Biopsy Brain Tumor.

Detailed Description

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Conditions

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Supratentorial Brain Tumor

Study Groups

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Tumor Resection

Group Type EXPERIMENTAL

ultrasound measurement of variations in the diameter of the sheath of the optic nerve

Intervention Type PROCEDURE

pre-and postoperative optic nerve and J2 and J5 for all patients

Biopsy Brain Tumor

Group Type ACTIVE_COMPARATOR

ultrasound measurement of variations in the diameter of the sheath of the optic nerve

Intervention Type PROCEDURE

pre-and postoperative optic nerve and J2 and J5 for all patients

Interventions

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ultrasound measurement of variations in the diameter of the sheath of the optic nerve

pre-and postoperative optic nerve and J2 and J5 for all patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Hospitalized for surgery of intracerebral tumors in the study group.
* Hospitalized for a biopsy of intracerebral tumor lesion in the control group.

Exclusion Criteria

* Age \<18 years
* Enucleation Prohibited to the achievement of an ocular ultrasound
* Hypersensitivity to gel
* Eye Wound
* Massive facial fracture
* Skin Infection Site
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertrand DEBAENE

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Other Identifiers

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DINO-NEURO

Identifier Type: -

Identifier Source: org_study_id

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