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

NCT01864499 | Completed

• 1 other identifier: DINO-NEURO
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Supratentorial Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Difference in mean changes that the sheath of postoperative optic nerve

  Difference in mean changes that the sheath of postoperative optic nerve and J2 between groups of patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor

  2 days

Secondary Outcomes (1)

• Difference in diameter of the sheath of the pre-and postoperative optic nerve

  5 days

Study Arms (2)

Tumor Resection

EXPERIMENTAL

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

Biopsy Brain Tumor

ACTIVE COMPARATOR

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

Interventions

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

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

Biopsy Brain Tumor; Tumor Resection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Officials

• Bertrand DEBAENE

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 29, 2013
• Primary Completion: June 1, 2015
• Last Updated: October 11, 2016

Record last verified: 2016-10