Optic Nerve Sheath Diameter (ONSD) With the Raised PCO2 and Internal Jugular Venous Occlusion

Elevated Intracranial Pressure (ICP) Clinical Trial

Official title:

Ultrasonographic Assessment of the Optic Nerve Sheath Diameter During Variations in PetCO2 and Controlled Internal Jugular Venous Occlusion: A Volunteer Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361658
• Other study ID #: UHN REB # 14-8014
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: June 2, 2017
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Elevated intracranial pressure (ICP) is a common and potentially life threatening condition arising from a variety of pathological conditions including traumatic brain injury (TBI), intracranial hemorrhage, subarachnoid hemorrhage and brain tumors. Monitoring the ICP is the most important aspect of the management of these patients. Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD). Transorbital ultrasonographic measurement of ONSD appears to be a noninvasive, relatively inexpensive bedside examination for the diagnosis of raised ICP. The investigators aimed to determine the changes in ONSD with acute controlled changes in ICP in healthy volunteers. The controlled changes in ICP will be produced by manipulating the PCO2 with the use of Respiract and jugular venous compression with the use of custom made neck collar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult healthy volunteers who are above the age of 18 ASA 1 Body mass index (BMI) less than and equal to 35 Neurologically normal subjects with no symptoms other than occasional non-severe headache

Exclusion Criteria:

BMI above 35 Lack of informed consent Language barrier Medical students and/or anesthesia residents going through the department as part of their rotation Pregnancy Frequent migraine headache

Related Conditions & MeSH terms

• Elevated Intracranial Pressure (ICP)
• Intracranial Hypertension

Intervention

Other:
• Ultrasonographic of the optic nerve sheath diameter
On both eyes of all subjects in supine position by two investigators.
• RespirAct™
Carbon dioxide Manipulation by RespirAct™ sequential gas delivery breathing circuit at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia).
• Neck collar
Internal jugular compression using a Neck collar will be applied at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia) and ONSD measurements will be done before and after the collar.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lashmi Venkatraghavan	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve sheath diameter at Normocapnia		1 day
Primary	Optic nerve sheath diameter at Hypercapnia		1 day
Primary	Optic nerve sheath diameter at Hypocapnia		1 day