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

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ClinicalTrials.gov Identifier: NCT02508181
Recruitment Status : Unknown
Verified July 2016 by Zehra Ipek ARSLAN, Kocaeli University.
Recruitment status was:  Recruiting
First Posted : July 24, 2015
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Zehra Ipek ARSLAN, Kocaeli University

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.

Condition or disease Intervention/treatment Phase
Intra Ocular Pressure Device: I-gel Device: LMA Supreme Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Intra Ocular Pressure After I-gel and Supreme Insertion
Study Start Date : July 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Active Comparator: I-gel intra ocular pressure
supraglottic airway device
Device: I-gel
supraglottic airway device without cuff

Active Comparator: LMA Supreme intra ocular pressure
supraglottic airway device
Device: LMA Supreme
supraglottic airway device with cuff




Primary Outcome Measures :
  1. intra ocular pressure [ Time Frame: 15 minutes ]
    measurement the intra ocular pressure before, during and after insertion of the device


Secondary Outcome Measures :
  1. vomiting [ Time Frame: 2 hour ]
  2. bradicardia [ Time Frame: 1 hour ]


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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508181


Locations
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Turkey
Kocaeli University School of Medicine Recruiting
Kocaeli, Turkey, 41900
Contact: Zehra I ARSLAN, Specialist       zehraipek48@gmail.com   
Principal Investigator: Zehra I ARSLAN, Specialist         
Sponsors and Collaborators
Kocaeli University
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Responsible Party: Zehra Ipek ARSLAN, Assistant Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT02508181    
Other Study ID Numbers: KOU KAEK 2015/14
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Keywords provided by Zehra Ipek ARSLAN, Kocaeli University:
intra ocular pressure
I-gel
LMA Supreme
strabismus surgery