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

NCT ID: NCT02508181

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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

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Intra Ocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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I-gel intra ocular pressure

supraglottic airway device

Group Type ACTIVE_COMPARATOR

I-gel

Intervention Type DEVICE

supraglottic airway device without cuff

LMA Supreme intra ocular pressure

supraglottic airway device

Group Type ACTIVE_COMPARATOR

LMA Supreme

Intervention Type DEVICE

supraglottic airway device with cuff

Interventions

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I-gel

supraglottic airway device without cuff

Intervention Type DEVICE

LMA Supreme

supraglottic airway device with cuff

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* pediatrics \> 2 years
* pediatrics \< 7 years
* undergoing strabismus surgery

Exclusion Criteria

* pediatrics \< 2 years
* pediatrics \> 7 years
* neuromuscular blockage using
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Ipek ARSLAN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University School of Medicine

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Zehra I ARSLAN, Specialist

Role: primary

[email protected]

Other Identifiers

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KOU KAEK 2015/14

Identifier Type: -

Identifier Source: org_study_id

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