The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

January 27, 2014 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool

Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

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

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial 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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients with American Society of Anesthesiologists physical status I-II
  2. aged 20-65 years
  3. requiring LMA Intubation under general anesthesia
  4. unlimited mouth open
  5. unlimited neck motion

Exclusion Criteria:

  1. mouth open < 3 cm
  2. limited neck motion
  3. BMI≧35 kg/m2

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foley group
The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion
Device: Foley Airway Stylet Tool
Experimental: I-Tool group
the ProSeal LMA was inserted with a standard introducer-tool
Device: introducer-tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with successful airway establishment
Time Frame: half an hour
successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions.
half an hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative sore throat
Time Frame: 2 days
sore throat recorded in recovery room and in the coming morning
2 days
hoarseness
Time Frame: 2 days
severity of hoarseness was recorded in recovery room and in the coming morning
2 days

Collaborators and Investigators

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

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Director: Kuang I Cheng, MD, PhD., Department of anesthesiology, Kaohsiung Medical University, Taiwan

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

March 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMHK-IRB-96023

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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