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

NCT03634176 | Completed DMC

• 1 other identifier: ABAY
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Intracranial Hypertension; Optic Nerve Sheath Diameter

Outcome Measures

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

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

Study Arms (3)

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

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).

Group H; Group M; Group P

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Dr. Miguel Pérez Carreño: lead

Study Sites (1)

Hospital Dr Miguel Perez Carreño

Caracas, Venezuela, Bolivarian Republic of, 1020, Venezuela

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, anesthesiologist.

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 16, 2018
• Study Start: February 1, 2017
• Primary Completion: August 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 8, 2018

Record last verified: 2018-11

Locations

VE (1)