Laryngeal Mask Airway for Adenoidectomies (LMAA)

March 9, 2016 updated by: Ozlem Ozmete, Baskent University

The Use of Laryngeal Mask Airway for Adenoidectomies: An Experience of 814 Paediatric Patients

The current study retrospectively assesses laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

814

Phase

  • Phase 4

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

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1-16 years of age
  • ASA I-II
  • Scheduled for elective adenoidectomy under general anesthesia with F-LMA between June 2012 and November 2015.

Exclusion Criteria:

  • Emergency
  • Extreme obesity
  • Sign of clinical significant 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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: F-LMA group
LMA were placed to 814 patients for adenoidectomy surgery. Researchers evaluated flexible laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.
Other: Flexible-Laryngeal Mask Airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of failed LMA (0=failed, 1=good)
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgeon satisfaction level (0=bad, 1=same, 2=good)
Time Frame: 3 year
3 year

Collaborators and Investigators

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

Sponsor

Baskent 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

June 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 21, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • KA 15-321

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.

Clinical Trials on Adenoidectomy Surgery

Clinical Trials on Flexible-Laryngeal Mask Airway

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe