The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter
ONSD laryngeal
1 other identifier
observational
230
1 country
1
Brief Summary
The goal of this observational trial is to study the effect of a laryngeal airway mask on the optic nerve sheath diameter, as a surrogate for intracranial pressure. The optic nerve sheath diameter of participants will be measured under general anesthesia, before, during and after insertion of a laryngeal airway mask.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2024
CompletedFirst Submitted
Initial submission to the registry
May 3, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2026
CompletedMay 8, 2024
May 1, 2024
2 years
May 3, 2024
May 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter
During surgery
Secondary Outcomes (2)
Effect of laryngeal ariway mask after insertion on optic nerve sheath diameter
During surgery
Effect of layngeal airway mask on optic nerve sheath diameter interna vs optic nerve sheath diameter externa
During surgery
Study Arms (1)
Observational cohort
ASA I-II patients scheduled for surgery under general anesthesia with a laryngeal airway mask
Interventions
Eligibility Criteria
ASA I-II patients scheduled for surgery under general anesthesia
You may qualify if:
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: aged 18 years or older, ASA I or ASA II, scheduled for elective surgery under general anesthesia, with a planned duration of \> 30 minutes, that can be routinely performed with a LMA.
You may not qualify if:
- Scheduled for head or neck surgery
- Scheduled for neurosurgery
- Scheduled for laparoscopic or thorascoscopic procedures
- Scheduled for procedures that require Trendelenburg or anti-Trendelenburg positioning
- Neurological disorders
- Glaucoma
- History of bilateral eye related trauma
- Intellectual disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus Medisch Centrum
Rotterdam, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 3, 2024
First Posted
May 8, 2024
Study Start
March 25, 2024
Primary Completion
March 25, 2026
Study Completion
March 25, 2026
Last Updated
May 8, 2024
Record last verified: 2024-05