Intracranial Pressure IncreaseONSD laryngealNCT06403592
The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter
An observational study of Intracranial Pressure Increase, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Increase
- What is being tested?
- optic nerve sheath diamater
- How many people
- 230 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Mar 2024to 25 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: ASA I-II patients scheduled for surgery under general anesthesia
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medisch Centrum
Rotterdam
Maissan
About this study
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.
- Conditions
- Intracranial Pressure Increase
- Being tested
- optic nerve sheath diamater
- Keywords
- Laryngeal airway mask, Optic Nerve sheath Diameter, Intracranial Pressure
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optic nerve sheath diamaterOther
Measurement of optic nerve sheath diameter
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | ASA I-II patients scheduled for surgery under general anesthesia with a laryngeal airway mask Receives: Other: optic nerve sheath diamater |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter
Measured: During surgery
Secondary outcomes (2)
Effect of laryngeal ariway mask after insertion on optic nerve sheath diameter
Measured: During surgery
Effect of layngeal airway mask on optic nerve sheath diameter interna vs optic nerve sheath diameter externa
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start25 Mar 2024
- Primary completion25 Mar 2026 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iscander M Maissan, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403592
- Sponsor's protocol ID
- ONSD laryngeal
- Acronym
- ONSD laryngeal
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT06403592
- Acronym / sponsor ID
- ONSD laryngeal / ONSD laryngeal
- Conditions
- Intracranial Pressure Increase
- Keywords
- Laryngeal airway mask, Optic Nerve sheath Diameter, Intracranial Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | Other: optic nerve sheath diamaterASA I-II patients scheduled for surgery under general anesthesia with a laryngeal airway mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ASA I-II patients scheduled for surgery under general anesthesia
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optic nerve sheath diamaterMeasurement of optic nerve sheath diameter | Other | Observational cohort |
Primary outcome
Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter
Time frame: During surgery
2 secondary outcomes
Effect of laryngeal ariway mask after insertion on optic nerve sheath diameter
Time frame: During surgery
Effect of layngeal airway mask on optic nerve sheath diameter interna vs optic nerve sheath diameter externa
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Maissan (+31628552301, i.maissan@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.