The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

July 21, 2010 updated by: Seoul National University Hospital

The 90-degree Rotational Insertion Technique for the Large Size ProSeal Laryngeal Mask Airway

The purpose of this study is to compare two insertion techniques of large size ProSeal laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ProSeal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in Asian population. First-time insertion success rate was lower and more time was required to achieve an effective airway even in well-trained physician. A number of techniques have been described to improve the insertion success rate. However, these techniques are only recommended to be used as backup when the digital or introducer tool techniques fail. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyonggi
      • Seongnam, Kyonggi, Korea, Republic of
        • Seoul National University Bundang Hospital

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

27 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

  • Predicted difficult airway
  • Mouth opening less than 2.5 cm
  • Present sore throat
  • High risk of aspiration

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard technique
Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual (insertion with help of index finger insertion)
Procedure: Insertion fo ProSeal laryngeal mask airway
Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique
EXPERIMENTAL: Rotational technique
The entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was fel
Procedure: Insertion fo ProSeal laryngeal mask airway
Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of Insertion at First Attempt
Time Frame: 5 minute
5 minute

Secondary Outcome Measures

Outcome Measure
Time Frame
Insertion Time, Sealing Pressure and Complication
Time Frame: 5 min - 4 hours
5 min - 4 hours

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jung-won Hwang, MD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (ESTIMATE)

August 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • jungwon

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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