The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter (ONSD laryngeal)

May 3, 2024 updated by: Iscander M Maissan, Erasmus Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medisch Centrum
        • Contact:
          • Maissan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

ASA I-II patients scheduled for surgery under general anesthesia

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational cohort
ASA I-II patients scheduled for surgery under general anesthesia with a laryngeal airway mask
Other: optic nerve sheath diamater
Measurement of optic nerve sheath diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter
Time Frame: During surgery
During surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of laryngeal ariway mask after insertion on optic nerve sheath diameter
Time Frame: During surgery
During surgery
Effect of layngeal airway mask on optic nerve sheath diameter interna vs optic nerve sheath diameter externa
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

March 25, 2026

Study Completion (Estimated)

March 25, 2026

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONSD laryngeal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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