Skip to main content
OpenTrials
Completed

NCT Number: NCT03634176

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intracranial Hypertension Brain Diseases Central Nervous System Diseases Nervous System Diseases Optic Nerve Sheath Diameter

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Dr Miguel Perez Carreño

Caracas, Venezuela, Bolivarian Republic of, 1020, Venezuela

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical nerve sheet diameter

Diagnostic Test

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).

Primary outcomes

  1. Optic nerve sheet diameter

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Dr. Miguel Pérez Carreño

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2018
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.