The Clinical Efficacy of Laryngeal Mask Airway in Elderly Patients: Comparison With Young Adults

February 17, 2014 updated by: Yonsei University

There are some differences between elderly and young adult patients regarding the anatomy of upper airways. Elderly patients have larger upper airways than young adult patients at all pharyngeal levels as revealed by CT. Another study explained that there is a progressive descent of the larynx and epiglottis with aging, which lengthens the upper airway and possibly makes it more likely to collapse.

The aim of this study is to compare the clinical efficacy of laryngeal mask airway (LMA) in elderly patients with young adults. In this study, the investigators will measure the ease of insertion, success rate of insertion, the time of insertion, oropharyngeal leak pressure, gastric leak pressure, fiberoptic position and intraoperative complications of the classic LMA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 20-40 and 65-85years
  • ASA status 1-2
  • Undergoing minor urologic surgery or lower extremity surgery
  • Undergoing general anesthesia using classic LMA

Exclusion Criteria:

  • Predicted difficult airway
  • Increased risk of aspiration
  • Gastroesophageal reflux
  • Neuromuscular disease
  • Significant acute or chronic lung 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

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: young adult group
young adult patients undergoing minor urologic surgery or lower extremity surgery
Procedure: classic LMA insertion
ACTIVE_COMPARATOR: elderly group
elderly patients undergoing minor urologic surgery or lower extremity surgery
Procedure: classic LMA insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oropharyngeal leak pressure
Time Frame: 24 hours
After successful placement of LMA, airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O(fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
24 hours

Collaborators and Investigators

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

Sponsor

Yonsei 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

December 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (ESTIMATE)

April 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2012-0711

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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