Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies

Sponsor
Hospital Dr. Miguel Pérez Carreño (Other)
Overall Status
Completed
CT.gov ID
NCT03634176
Collaborator
(none)
90
1
19.9
4.5

Study Details

Study Description

Brief Summary

Measurement of the diameter of the sheath of the optic nerve in patients hospitalized in intensive care, with increased intracranial pressure (> 20mmHg) as a substitute measure for diagnosis and follow-up before and after different non-invasive strategies.

Three groups were created in which, through strategies already proven and non-invasive (mannitol, hypertonic solution 7.5% NaCl, reverse trendelenburg) to decrease the intracranial pressure, the optic nerve diameter measurement was performed and simultaneously the investigators monitored intracranial pressure through an intraventricular catheter continuously to determine if both correspond

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: optical nerve sheet diameter

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Group M

both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after received 0.5gr/kg 20% mannitol

Diagnostic Test: optical nerve sheet diameter
The ONSD in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged. No pressure was applied to the orbit. At each time point, measurements were taken within 5 min. The measurements were made before (T1) and after some of the strategies according to group 30 min (T2), 60 min (T3), and 90 min (T4).

Group H

both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after received 1.5 ml/kg 7.5% NaCl solution

Diagnostic Test: optical nerve sheet diameter
The ONSD in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged. No pressure was applied to the orbit. At each time point, measurements were taken within 5 min. The measurements were made before (T1) and after some of the strategies according to group 30 min (T2), 60 min (T3), and 90 min (T4).

Group P

both optic nerve sheath diameter (the posterior 3mm of the papilla) before and after patients were positioned on reverse Trendelenburg position 30 degrees higher than the feet

Diagnostic Test: optical nerve sheet diameter
The ONSD in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged. No pressure was applied to the orbit. At each time point, measurements were taken within 5 min. The measurements were made before (T1) and after some of the strategies according to group 30 min (T2), 60 min (T3), and 90 min (T4).

Outcome Measures

Primary Outcome Measures

  1. Optic nerve sheet diameter [immediately before administering the treatment according to the group and every 30 minutes after administering the treatment until 90 min.]

    The optic nerve sheet diameter in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients (≥ 18 years old) with traumatic or non-traumatic elevated ICP (defined as greater than 20 mm Hg for at least 10min)

  • Hospitalized in ICU

  • Patients with ICP continuous measurement through an intraventricular catheter

  • Respiratory rate maintained at 10-18 breaths/min to maintain the end tidal carbon dioxide partial pressure between 35 and 40 mmHg

  • Peak airway pressure <35 cmH2O

  • Positive end-expiratory pressure <5 cmH2O

Exclusion Criteria:
  • Patients who had undergone cranial decompression surgery

  • Patients with ocular pathology

  • Patients who had previously undergone eye surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Dr Miguel Perez Carreño Caracas Venezuela, Bolivarian Republic Of Venezuela 1020

Sponsors and Collaborators

  • Hospital Dr. Miguel Pérez Carreño

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aldo Saad Diab, Principal Investigator, anesthesiologist., Hospital Dr. Miguel Pérez Carreño
ClinicalTrials.gov Identifier:
NCT03634176
Other Study ID Numbers:
  • ABAY
First Posted:
Aug 16, 2018
Last Update Posted:
Nov 8, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2018