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Comparison of Two Insertion Technique of I-gel (I-gel90)

Primary Purpose

Prostate Cancer, Prostate Tumor, Bladder Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rotational technique
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring success

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Rotation

    Arm Description

    i-gel will be inserted without rotation

    Rotational technique applied

    Outcomes

    Primary Outcome Measures

    The success rate of insertion
    check oropharyngeal leakage at pressure 12 cmH2O

    Secondary Outcome Measures

    postoperative sore throat
    severe/moderate/minimal/none

    Full Information

    First Posted
    March 19, 2013
    Last Updated
    May 3, 2013
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01826565
    Brief Title
    Comparison of Two Insertion Technique of I-gel
    Acronym
    I-gel90
    Official Title
    Comparison of Two Insertion Technique of I-gel: Standard Versus 90-degree Rotation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    May 2014 (Anticipated)
    Study Completion Date
    July 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Prostate Tumor, Bladder Cancer, Bladder Tumor
    Keywords
    success

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    i-gel will be inserted without rotation
    Arm Title
    Rotation
    Arm Type
    Experimental
    Arm Description
    Rotational technique applied
    Intervention Type
    Procedure
    Intervention Name(s)
    Rotational technique
    Other Intervention Name(s)
    90 degree rotation technique
    Intervention Description
    90 degree rotation
    Primary Outcome Measure Information:
    Title
    The success rate of insertion
    Description
    check oropharyngeal leakage at pressure 12 cmH2O
    Time Frame
    up to 30 min.
    Secondary Outcome Measure Information:
    Title
    postoperative sore throat
    Description
    severe/moderate/minimal/none
    Time Frame
    up to 2 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hee-Pyung Park, MD PhD
    Organizational Affiliation
    Seoul National University of Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hyun-Chang Kim, MD
    Organizational Affiliation
    Seoul National University of Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Two Insertion Technique of I-gel

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