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

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ClinicalTrials.gov Identifier: NCT02361658
Recruitment Status : Completed
First Posted : February 12, 2015
Last Update Posted : June 5, 2017
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Lashmi Venkatraghavan, University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment
Elevated Intracranial Pressure (ICP) Other: Ultrasonographic of the optic nerve sheath diameter Other: RespirAct™ Other: Neck collar

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonographic Assessment of the Optic Nerve Sheath Diameter During Variations in PetCO2 and Controlled Internal Jugular Venous Occlusion: A Volunteer Study
Study Start Date : January 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Ultrasonographic of the optic nerve sheath diameter
    On both eyes of all subjects in supine position by two investigators.
  • Other: RespirAct™
    Carbon dioxide Manipulation by RespirAct™ sequential gas delivery breathing circuit at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia).
  • Other: 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.


Primary Outcome Measures :
  1. Optic nerve sheath diameter at Normocapnia [ Time Frame: 1 day ]
  2. Optic nerve sheath diameter at Hypercapnia [ Time Frame: 1 day ]
  3. Optic nerve sheath diameter at Hypocapnia [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult healthy volunteers
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361658


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
Lashmi Venkatraghavan
University Health Network, Toronto
Investigators
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Principal Investigator: Lashmi Venkatraghavan, MD Assistant Professor, Toronto Western Hospital, University Health Network

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Responsible Party: Lashmi Venkatraghavan, Assistant Professor, Department of Anesthesia, Toronto Western Hospital, Toronto, Canada, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02361658     History of Changes
Other Study ID Numbers: UHN REB # 14-8014
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases