Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

NCT ID: NCT04686344

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2021-08-30

Brief Summary

Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of the skull results in increased ICP, which may lead to life-threatening structural alterations in the brain or cerebral blood flow, thus causing oxygen deprivation and ischemia in the brain.

Methods for ICP monitoring can be divided into invasive and noninvasive approaches. In fluid-based systems, external ventricular drainage (EVD) has been considered the gold standard.

Clinicians have found several noninvasive methods that can be used as surrogates for invasive methods for ICP measurement. The optic nerve, as part of the central nervous system, is wrapped by the dural sheath. The optic nerve sheath (ONS) is the continuation of the subarachnoid space at the optic nerve, and its tissues are connected with the subarachnoid space. Thus, an increase in ICP results in a corresponding elevation of the ONS diameter (ONSD).

Hypertonic solutions such as mannitol and hypertonic saline (HTS) are recommended early in the management of ICH after severe TBI . They provide therapeutic benefit along with a wide therapeutic margin. The most recent BTF guidelines stated "although hyperosmolar therapy may lower intracranial pressure, there was insufficient evidence about effects on clinical outcomes to support a specific recommendation, or to support use of any specific hyperosmolar agent".

Conditions

Optic Nerve Sheath; Hypertonic Saline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypertonic saline continuous infusion Group

will receive Hypertonic saline continuous infusion

Group Type: ACTIVE_COMPARATOR

continuous infusion of Hypertonic saline

Intervention Type: DRUG

continuous infusion over a period of 48 hours

Hypertonic saline intermittent boluses Group

will receive Hypertonic saline intermittent boluses for 48 hours

Group Type: ACTIVE_COMPARATOR

intermittent boluses of Hypertonic saline

Intervention Type: DRUG

intermittent boluses every 6 hours over 30 min for 48 hours

Interventions

intermittent boluses of Hypertonic saline

intermittent boluses every 6 hours over 30 min for 48 hours

Intervention Type: DRUG

continuous infusion of Hypertonic saline

continuous infusion over a period of 48 hours

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who having Isolated traumatized brain injury (not for surgical intervention)

2. 3<GCS ≤ 12.

3. Both genders.

4. Age ≥ 18 and ≤ 60Years.

5. Physical status ASA I - III.

6. Cut off value for optic nerve sheath diameter (ONSD) as 5.5 mm to diagnose increase in ICP> 20 mm Hg.

Exclusion Criteria

1. Patients' first-degree relatives' refusal to sign the consent.

2. GCS (Glasgow coma score) >12 or GCS of 3.

3. Contraindication to hypertonic saline: pregnancy, coagulopathy and cardiac dysfunction.

4. Spinal cord injury, orbital injury, optic nerve injury and optic neuritis.

5. Multi organ affection.

6. Serum Na level ≥ 150 mmol/L at admission to ICU.

7. Hypotension requiring vasopressors to maintain MAP above 60 mmHg.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university

Cairo, , Egypt

Faculty of Medicine, Cairo University.

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-383-2020

Identifier Type: -

Identifier Source: org_study_id