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

Completed

• Conditions: Intracranial Hypertension; Optic Nerve Sheath Diameter

• Registration Number: NCT03634176
• Lead Sponsor: Hospital Dr. Miguel Pérez Carreño

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2018-08-11
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Primary Completion: 2018-08-30
• Study Completion: 2018-09-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Dr Miguel Perez Carreño; 🇻🇪 Caracas, Venezuela, Bolivarian Republic Of, Venezuela