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CompletedNCT03634176Updated Nov 8, 2018

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

An observational study in Intracranial Hypertension and Optic Nerve Sheath Diameter, sponsored by Hospital Dr. Miguel Pérez Carreño. Completed at 1 site in Venezuela. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-08.

Sponsored by Hospital Dr. Miguel Pérez Carreño · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 65 Years
Sex
All
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Study 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

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Conditions studied

  • Intracranial Hypertension
  • Optic Nerve Sheath Diameter
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In context

Intracranial Hypertension

185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 80 observational studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

This is the only study on the registry with Hospital Dr. Miguel Pérez Carreño as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients hospitalized in the intensive care unit of the Dr. Migel Pérez Carreño hospital with increased intracranial pressure of traumatic or non-traumatic etiology.

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

Exclusion Criteria:

  • Patients who had undergone cranial decompression surgery
  • Patients with ocular pathology
  • Patients who had previously undergone eye surgery
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testoptical 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).

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What researchers measure

Primary outcomes

  1. Optic nerve sheet diameter

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

    Time frame: immediately before administering the treatment according to the group and every 30 minutes after administering the treatment until 90 min.

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Study locations

1 site
  • Hospital Dr Miguel Perez Carreño
    Caracas, Venezuela, Bolivarian Republic Of 1020, Venezuela
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03634176
Lead sponsor
Hospital Dr. Miguel Pérez Carreño
Responsible party
Aldo Saad Diab (Principal Investigator, anesthesiologist., Hospital Dr. Miguel Pérez Carreño) — Principal investigator
First posted
Aug 16, 2018
Start date
Feb 1, 2017
Primary completion
Aug 30, 2018
Completion
Sep 30, 2018
Last update
Nov 8, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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