Intra Ocular PressurePhase 4NCT02508181

Comparison of Intra Ocular Pressure After Insertion of the LMA Supreme and LMA Proseal in Pediatric Patients

A Phase 4 study testing I-gel and LMA Supreme in people with Intra Ocular Pressure, run by Kocaeli University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures. Read more about this study

Who is it for?: Ages 2 to 7 years
Conditions the study is for: Intra Ocular Pressure
What is being tested?: I-gel and LMA Supreme
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Jul 2015to Sep 2016
Phase: Phase 4
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 2 to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

pediatrics > 2 years
pediatrics < 7 years
undergoing strabismus surgery

Who cannot join

pediatrics < 2 years
pediatrics > 7 years
neuromuscular blockage using

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting

Kocaeli University School of Medicine
Kocaeli, 41900
Zehra I ARSLAN, Specialist, zehraipek48@gmail.com
Zehra I ARSLAN, Specialist
Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Intra Ocular Pressure After I-gel and Supreme Insertion

The investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures.

Read the detailed description

We already know that tracheal intubation increased intraocular pressure. We tried to evaluate the change of the intra ocular pressure increase before, during and after insertion the I-gel and LMA Supreme supraglottic airway devices. We enrolled the pediatric patients who are undergoing to strabismus surgery.

Conditions: Intra Ocular Pressure
Being tested: I-gel, LMA Supreme
Keywords: intra ocular pressure, I-gel, LMA Supreme, strabismus surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

I-gelDevice
supraglottic airway device without cuff
LMA SupremeDevice
supraglottic airway device with cuff

Study groups in NCT02508181
Study group	Role	What they receive
I-gel intra ocular pressure	Active comparator	supraglottic airway device Receives: Device: I-gel
LMA Supreme intra ocular pressure	Active comparator	supraglottic airway device Receives: Device: LMA Supreme

What is being measured

The primary outcome is the main question the study is designed to answer.

intra ocular pressure
measurement the intra ocular pressure before, during and after insertion of the device
Measured: 15 minutes

Secondary outcomes (2)

vomiting
Measured: 2 hour
bradicardia
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Sep 2016

First posted24 Jul 2015 (estimated)
Study startJul 2015
Primary completionSep 2016 (estimated)
Study completionSep 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intra Ocular PressureStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 57 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02508181
Sponsor's protocol ID: KOU KAEK 2015/14
Status last verified: Jul 2016
First submitted: 22 Jul 2015
Last updated: 20 Jul 2016
Results posted: No
Data monitoring committee: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
Recruiting
Acute Intra Ocular Pressure Monitoring After Aflibercept 8mg/0.07mL
Macular Diseases
Active, not recruitingObservational study
MINIject Global Long-Term Follow-up Study
Open Angle Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure
Increase Intra Cranial Pressure, Traumatic Brain Injury
Enrolling by invitation
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
Primary Open-angle Glaucoma, Cataract

All Intra Ocular Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intra Ocular Pressure After I-gel and Supreme Insertion
ClinicalTrials.gov ID: NCT02508181
Acronym / sponsor ID: KOU KAEK 2015/14
Conditions: Intra Ocular Pressure
Keywords: intra ocular pressure, I-gel, LMA Supreme, strabismus surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 57 participants (estimated)
Lead sponsor: Kocaeli UniversityUniversity, hospital or other
Study start: Jul 2015
Primary completion: Sep 2016 (estimated)
Study completion: Sep 2016 (estimated)
First posted: 24 Jul 2015 (estimated)
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 investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
I-gel intra ocular pressure	Active comparator	Device: I-gelsupraglottic airway device
LMA Supreme intra ocular pressure	Active comparator	Device: LMA Supremesupraglottic airway device

Who may qualify

Ages: 2 to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

pediatrics > 2 years
pediatrics < 7 years
undergoing strabismus surgery

Key exclusion criteria (3 listed)

pediatrics < 2 years
pediatrics > 7 years
neuromuscular blockage using

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
I-gelsupraglottic airway device without cuff	Device	I-gel intra ocular pressure
LMA Supremesupraglottic airway device with cuff	Device	LMA Supreme intra ocular pressure

Primary outcome

intra ocular pressure
Time frame: 15 minutes
measurement the intra ocular pressure before, during and after insertion of the device

2 secondary outcomes

vomiting
Time frame: 2 hour
bradicardia
Time frame: 1 hour

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.

Related trials for Intra Ocular Pressure

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
Recruiting
Acute Intra Ocular Pressure Monitoring After Aflibercept 8mg/0.07mL
Macular Diseases
Active, not recruitingObservational study
MINIject Global Long-Term Follow-up Study
Open Angle Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure
Increase Intra Cranial Pressure, Traumatic Brain Injury
Enrolling by invitation
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
Primary Open-angle Glaucoma, Cataract

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.

Kocaeli University School of Medicine

Kocaeli, Turkey (Türkiye)

zehraipek48@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing I-gel and LMA Supreme in people with Intra Ocular Pressure, run by Kocaeli University at 1 site in Turkey (Türkiye).

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 3 inclusion and 3 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 20 Jul 2016. 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 Turkey (Türkiye). 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intra ocular pressure (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02508181.

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 20 Jul 2016.