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

May 3, 2013 updated by: Seoul National University Hospital

Comparison of Two Insertion Technique of I-gel: Standard Versus 90-degree Rotation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate of insertion
Time Frame: up to 30 min.
check oropharyngeal leakage at pressure 12 cmH2O
up to 30 min.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative sore throat
Time Frame: up to 2 days
severe/moderate/minimal/none
up to 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2013

Last Update Submitted That Met QC Criteria

May 3, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPPark

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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