N/A
N=100
Optic Nerve Sheath Diameter (ONSD) With the Raised PCO2 and Internal Jugular Venous Occlusion
Elevated Intracranial Pressure (ICP)
Bottom Line
View on ClinicalTrials.gov: NCT02361658 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Changes in ONSD in mm With Changes in ICP in Healthy Volunteers. — 4.2 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ultrasonographic of the optic nerve sheath diameter (Other); RespirAct™ (Other); Neck collar (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lashmi Venkatraghavan
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in ONSD in mm With Changes in ICP in Healthy Volunteers. |
4.2 | — |
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). 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02361658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.