Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04686344
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Actual Duration (Months): 8.3
• Patients Per Site: 25
• Patients Per Site Per Month: 3

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Optic Nerve Sheath; Hypertonic Saline	Drug: intermittent boluses of Hypertonic saline; Drug: continuous infusion of Hypertonic saline	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Sonography of the Optic Nerve Sheath Diameter for Comparison Between the Effects of Continuous Infusion of 3%Hypertonic Saline With Intermittent Boluses Versus in Patients With Traumatic Brain Injury.
• Actual Study Start Date: Dec 21, 2020
• Actual Primary Completion Date: Aug 10, 2021
• Actual Study Completion Date: Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hypertonic saline continuous infusion Group will receive Hypertonic saline continuous infusion	Drug: continuous infusion of Hypertonic saline; continuous infusion over a period of 48 hours
Active Comparator: Hypertonic saline intermittent boluses Group will receive Hypertonic saline intermittent boluses for 48 hours	Drug: intermittent boluses of Hypertonic saline; intermittent boluses every 6 hours over 30 min for 48 hours

Outcome Measures

Primary Outcome Measures

1. Diameter of Optic nerve sheath [UP TO 48 HOURS]

   assessment tool for Intracranial pressure

Secondary Outcome Measures

1. intracranial pressure [up to 72 hours]

   Rebound increase intracranial pressure

2. level of Conscious [UP TO 30 DAY]

   Glasgow Coma Score : A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

7. Exclusion criteria

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

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

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

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

12. Multi organ affection.

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university	Cairo		Egypt	11451
2	Faculty of Medicine, Cairo University.	Cairo		Egypt	11451

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University
• ClinicalTrials.gov Identifier: NCT04686344
• Other Study ID Numbers: MS-383-2020
• First Posted: Dec 28, 2020
• Last Update Posted: Sep 17, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 17, 2021