Trial Outcomes & Findings for Optic Nerve Sheath Diameter (ONSD) With the Raised PCO2 and Internal Jugular Venous Occlusion (NCT NCT02361658)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

1 day

Results posted on

2025-03-17

Participant Flow

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

Participant milestones

Participant milestones
Measure	Ultrasonographic of the Optic Nerve Sheath Diameter Use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasonographic of the Optic Nerve Sheath Diameter n=100 Participants Use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP
Age, Customized Participants	100 Participants n=100 Participants
Sex: Female, Male Female	50 Participants n=100 Participants
Sex: Female, Male Male	50 Participants n=100 Participants
Region of Enrollment Canada	100 participants n=100 Participants
Intracranial pathology scheduled for elective or emergency surgery	100 Participants n=100 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ultrasonographic of the Optic Nerve Sheath Diameter n=100 Participants 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.
Changes in ONSD in mm With Changes in ICP in Healthy Volunteers.	4.2 mm Standard Deviation 0.7

Adverse Events

Ultrasonographic of the Optic Nerve Sheath Diameter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emad Al Azazi

Toronto Western Hospital, University Health Network

Phone: 4166035800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place