Selection of Laryngeal Mask Airway in Patients With Slender Somatotype

April 7, 2016 updated by: XiQiang Huang

Selection of Laryngeal Mask Airway When Actual Body Weight Much Less Than Ideal Body Weight in Adult Patients

The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's recommendation based on the patient's ideal weight. But sometimes the patient is tall and slim, the actual weight is much less than the ideal weight. This phenomenon might affect the success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal Mask Airway size based on ideal weight could improve the success rate of insertion; therefore, this study was designed to prove whether this conclusion also applies to the tall and thin patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

One hundred and eighteen patients adult patients，actual body weight much less than ideal body weight will be assigned randomly to two groups (Actual weight Group or Ideal weight Group). Size selection was guided by the recommendations of manufacturer, patients will be based on the actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.

The success rate of first attempt，number of adjustments, insertion time, ease of insertion, overall success rate, oropharyngeal leak pressure and fiberoptic view will be recorded and compared. The occurrences of respiratory complications such as sore throat, hoarseness, and dysphonia will be observed and recorded.

Study Type

Interventional

Enrollment (Anticipated)

118

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.

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult Patients undergo elective surgery of American Society of Anesthesiologists (ASA) physical status 1-2, aged from 18 to 60;
  2. Patients' actual weight much less than ideal weight.

Exclusion Criteria:

  1. Patients with gastroesophageal reflux disease;
  2. Patients with predicted difficult airway;
  3. Patients with preexisting airway diseases or significant upper airway infection.

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Actual weight Group
Patients in Actual weight Group: The selection of Laryngeal Mask Airway classic will be based on actual body weight, followed the recommendations of manufacturer (size 3 for weight < 50 kg, size 4 for weight 50-70 kg, and size 5 for weight > 70 kg ).
Device: Laryngeal Mask Airway
If there were any conflicts of the Laryngeal Mask Airway classic size selection in slim patients by the actual or ideal body weight, size selection will based on actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.
EXPERIMENTAL: Ideal weight Group
Patients in Ideal weight Group: The selection of Laryngeal Mask Airway classic will be based on ideal body weight, followed the recommendations of manufacturer ( size 3 for weight < 50 kg, size 4 for weight 50-70 kg, and size 5 for weight > 70 kg ).
Device: Laryngeal Mask Airway
If there were any conflicts of the Laryngeal Mask Airway classic size selection in slim patients by the actual or ideal body weight, size selection will based on actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The success rate of Laryngeal Mask Airway first insertion
Time Frame: Six months
Six months

Collaborators and Investigators

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

Sponsor

XiQiang Huang

Collaborators

Sun Yat-sen 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

April 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2016

Study Completion (ANTICIPATED)

November 1, 2016

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (ESTIMATE)

April 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSPH20160303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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