Laryngeal Mask Airway With Video-stylet

October 18, 2016 updated by: Hee-Soo Kim, Seoul National University Hospital

Video Stylet Guided Laryngeal Mask Airway Insertion in Pediatrics: a Randomized Controlled Trial

In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided laryngeal mask airway real time insertion technique with the standard recommended index finger-guided insertion technique in pediatric patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Compare the efficacy and safety of using video-stylet guided laryngeal mask airway insertion with blind technique

Study Type

Interventional

Enrollment (Anticipated)

108

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

2 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatric patients undergoing general anesthesia using laryngeal mask airways

Exclusion Criteria:

  • recent (within 2 weeks) upper respiratory 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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Videostylet
Laryngeal mask airway insertion using video stylet guided technique
Device: Laryngeal mask insertion with videostylet guided technique
Active Comparator: Blind
Laryngeal mask insertion using standard index finger-guided technique
Device: Laryngeal mask insertion with standard blind technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the time required for inserting the laryngeal mask airways
Time Frame: time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds

Secondary Outcome Measures

Outcome Measure
Time Frame
the numbers of insertion attempt
Time Frame: interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • H-1609-090-792

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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