Comparison of Intra Ocular Pressure After Insertion of th... | NCT02508181

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

NCT02508181

Sponsor

Kocaeli University

Status

Unknown status

Last Update Posted

Jul 20, 2016Estimated

Enrollment

57Estimated

Phase

Phase 4

Conditions

Intra Ocular Pressure

Interventions

I-gel
LMA Supreme

Countries

Turkey (Türkiye)

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

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

Jul 2015

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jul 22, 2015

First Submission Date that Met QC Criteria

Jul 23, 2015

First Posted Date

Jul 24, 2015Estimated

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

Jul 19, 2016

Last Update Posted Date

Jul 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I-gel intra ocular pressure	Active Comparator	supraglottic airway device	Device: I-gel
LMA Supreme intra ocular pressure	Active Comparator	supraglottic airway device	Device: LMA Supreme

Interventions

Name	Type	Description	Arm Group Labels	Other Names
I-gel	Device	supraglottic airway device without cuff	I-gel intra ocular pressure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intra ocular pressure	measurement the intra ocular pressure before, during and after insertion of the device	15 minutes

Secondary Outcomes

Measure	Description	Time Frame
vomiting		2 hour
bradicardia		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatrics > 2 years
pediatrics < 7 years
undergoing strabismus surgery

Exclusion Criteria:

pediatrics < 2 years
pediatrics > 7 years
neuromuscular blockage using

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University School of Medicine	Recruiting	Kocaeli		41900	Turkey (Türkiye)

Type	Date	Date Unknown
Release	Feb 2, 2017
Reset	Mar 22, 2017
Release	Apr 27, 2021
Reset	May 17, 2021

Submission Tracking

Estimated Results First Submitted Date

Feb 2, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 2, 2017			Mar 22, 2017
Apr 27, 2021