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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

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ClinicalTrials.gov Identifier: NCT01864499
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Supratentorial Brain Tumor Procedure: ultrasound measurement of variations in the diameter of the sheath of the optic nerve Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Brain Tumors

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864499


Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Principal Investigator: Bertrand DEBAENE Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01864499     History of Changes
Other Study ID Numbers: DINO-NEURO
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases