NCT02508181

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

July 22, 2015

Last Update Submit

July 19, 2016

Conditions

Intra Ocular Pressure

Keywords

intra ocular pressureI-gelLMA Supremestrabismus surgery

Outcome Measures

Primary Outcomes (1)

  • intra ocular pressure

    measurement the intra ocular pressure before, during and after insertion of the device

    15 minutes

Secondary Outcomes (2)

  • vomiting

    2 hour

  • bradicardia

    1 hour

Study Arms (2)

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

I-gelDEVICE

supraglottic airway device without cuff

I-gel intra ocular pressure
LMA SupremeDEVICE

supraglottic airway device with cuff

LMA Supreme intra ocular pressure

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • pediatrics \< 2 years
  • pediatrics \> 7 years
  • neuromuscular blockage using

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 24, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

TU(1)