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

Supratentorial Brain Tumor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864499
• Other study ID #: DINO-NEURO
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: October 10, 2016

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2015
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Hypertension
• Supratentorial Brain Tumor

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in diameter of the sheath of the pre-and postoperative optic nerve	Difference in diameter of the sheath of the pre-and postoperative optic nerve and J2 and J5 for all patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor.	5 days