Elevated Intracranial Pressure (ICP)NCT02361658
Optic Nerve Sheath Diameter (ONSD) With the Raised PCO2 and Internal Jugular Venous Occlusion
An observational study of Elevated Intracranial Pressure (ICP), run by Lashmi Venkatraghavan at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elevated Intracranial Pressure (ICP)
- What is being tested?
- Ultrasonographic of the optic nerve sheath diameter, RespirAct™ and Neck collar
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of the Optic Nerve Sheath Diameter During Variations in PetCO2 and Controlled Internal Jugular Venous Occlusion: A Volunteer Study
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.
Read the detailed description
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.
- Conditions
- Elevated Intracranial Pressure (ICP)
- Being tested
- Ultrasonographic of the optic nerve sheath diameter, RespirAct™, Neck collar
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic of the optic nerve sheath diameterOther
On both eyes of all subjects in supine position by two investigators.
RespirAct™Other
Carbon dioxide Manipulation by RespirAct™ sequential gas delivery breathing circuit at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia).
Neck collarOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ONSD in mm With Changes in ICP in Healthy Volunteers.
Transorbital ultrasound will be used for measuring the changes in ONSD. 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Elevated Intracranial Pressure (ICP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lashmi Venkatraghavan
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor-investigator, Lashmi Venkatraghavan, University Health Network, Toronto
- Investigators
- Lashmi Venkatraghavan, MD, Principal investigator, Assistant Professor, Toronto Western Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361658
- Sponsor's protocol ID
- UHN REB # 14-8014
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2015
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of the Optic Nerve Sheath Diameter During Variations in PetCO2 and Controlled Internal Jugular Venous Occlusion: A Volunteer Study
- ClinicalTrials.gov ID
- NCT02361658
- Acronym / sponsor ID
- UHN REB # 14-8014
- Conditions
- Elevated Intracranial Pressure (ICP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lashmi VenkatraghavanUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Jan 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult healthy volunteers
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic of the optic nerve sheath diameterOn 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 collarInternal 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. | Other | – |
Primary outcome
Changes in ONSD in mm With Changes in ICP in Healthy Volunteers.
Time frame: 1 day
Transorbital ultrasound will be used for measuring the changes in ONSD. 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lashmi Venkatraghavan, MD principal investigator
Assistant Professor, Toronto Western Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Intracranial Pressure (ICP), run by Lashmi Venkatraghavan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ONSD in mm With Changes in ICP in Healthy Volunteers. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.