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I-gel90: Comparison of Two Insertion Technique of I-gel

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01826565
Collaborator
(none)
100
Enrollment
2
Arms
14
Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the efficacy of rotational technique in the insertion of i-gel

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rotational technique
 N/A

Detailed Description

The i-gel is one of the 2nd generation supraglottic airways. The rotational technique is known to increase the success rate of insertion of other supraglottic airways. The investigators try to evaluate the efficacy of rotational technique in the insertion of i-gel.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Two Insertion Technique of I-gel: Standard Versus 90-degree Rotation
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
May 1, 2014
Anticipated Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

i-gel will be inserted without rotation
Experimental: Rotation

Rotational technique applied

Procedure: Rotational technique
90 degree rotation
Other Names:
  • 90 degree rotation technique

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The success rate of insertion [up to 30 min.]

      check oropharyngeal leakage at pressure 12 cmH2O

    Secondary Outcome Measures

    1. postoperative sore throat [up to 2 days]

      severe/moderate/minimal/none

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM
    Exclusion Criteria:

    • History of recent postoperative sore throat

    • History of difficult airway

    • Mouth opening < 2.5 cm

    • Emergency operation

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Hee-Pyung Park, MD PhD, Seoul National University of Hospital
    • Principal Investigator: Hyun-Chang Kim, MD, Seoul National University of Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01826565
    Other Study ID Numbers:
    • HPPark
    First Posted:
    Apr 8, 2013
    Last Update Posted:
    May 6, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Seoul National University Hospital
    success
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of May 6, 2013