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

Intracranial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634176
• Other study ID #: ABAY
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2018
• Source: Hospital Dr. Miguel Pérez Carreño
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Hypertension
• Optic Nerve Sheath Diameter

Intervention

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).

Locations

Country	Name	City	State
Venezuela	Hospital Dr Miguel Perez Carreño	Caracas	Venezuela, Bolivarian Republic Of

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Dr. Miguel Pérez Carreño

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately before administering the treatment according to the group and every 30 minutes after administering the treatment until 90 min.