The Effect of a Laryngeal Mask Airway on Optic Nerve Shea... | NCT06403592

Studies
The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter

NCT06403592

Sponsor

Erasmus Medical Center

Status

Unknown status

Last Update Posted

May 8, 2024Actual

Enrollment

230Estimated

Phase

Not provided

Conditions

Intracranial Pressure Increase

Interventions

optic nerve sheath diamater

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2024Actual

Primary Completion Date

Mar 25, 2026Estimated

Completion Date

Mar 25, 2026Estimated

First Submitted Date

May 3, 2024

First Submission Date that Met QC Criteria

May 3, 2024

First Posted Date

May 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2024

Last Update Posted Date

May 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational cohort		ASA I-II patients scheduled for surgery under general anesthesia with a laryngeal airway mask	Other: optic nerve sheath diamater

Interventions

Name	Type	Description	Arm Group Labels	Other Names
optic nerve sheath diamater	Other	Measurement of optic nerve sheath diameter	Observational cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ASA I-II patients scheduled for surgery under general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. Maissan	Contact	+31628552301		i.maissan@erasmusmc.nl
Rutger Hollestelle	Contact	+31613997877		r.hollestelle@erasmusmc.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus Medisch Centrum	Recruiting	Rotterdam			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D019586	Intracranial Hypertension

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided