Supreme LMA and Proseal LMA in Prone Anesthetized Patient (SPLMA)

March 15, 2013 updated by: Chatchai Prechawai, Prince of Songkla University

Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position

There is no significant difference about success rate of two devices.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There is no significant difference about success rate of two device: efficacy and safety

Study Type

Interventional

Enrollment (Actual)

100

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

  • Thailand
    • Songkhla
      • Had yai, Songkhla, Thailand, 90110
        • Faculty of Medicine, Prince of Songkla University

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

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society Anesthesiologists physical status I-III
  • Patient undergo elective orthopedics surgery in prone position under general anaesthesia

Exclusion Criteria:

  • Age <15year
  • Non-fast
  • Morbid obesity (BMI > 35kg/m2)
  • Pregnancy
  • Known or predicted difficult airway
  • GERD
  • History of laryngeal problem (injury,subglottic stenosis)
  • Local pharyngeal problem (abscess,tumor)
  • Poor dentation
  • Pulmonary disease

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Supreme
Supreme LMA
Device: Supreme LMA
Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion
Active Comparator: Proseal
Proseal LMA
Device: Proseal LMA
Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate of insertion (quality of ventilation)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Ease of insertion, Complication and Glottic seal pressure
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

Investigators

  • Study Chair: Chatchai Prechawai, Prince of Songkla University

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

October 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLMA-100
  • SPLMA-100-CPrechawai (Registry Identifier: CPrechawai)

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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