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

October 10, 2016 updated by: Poitiers University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tumor Resection
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
Active Comparator: Biopsy Brain Tumor
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean changes that the sheath of postoperative optic nerve
Time Frame: 2 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in diameter of the sheath of the pre-and postoperative optic nerve
Time Frame: 5 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Bertrand DEBAENE, Poitiers university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DINO-NEURO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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