Endotracheal Tube Shapes for Intubation With Videolaryngoscope

July 5, 2018 updated by: Eunah Cho, MD

Comparison of Endotracheal Tube Shapes for Intubation With Videolaryngoscope in Normal Airways

In this study, investigators will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since the intubation using videolaryngoscope does not need straightened oral-pharyngeal-laryngeal axis, certain curvature of endotracheal tube is needed for the successful intubation using the videolaryngoscope.

Participants in both groups will be intubated with videolaryngoscope (McGrath MAC®). Stylet will be inserted in the endotracheal tubes and will be bent to a specific shape by the assigned group. In the J-shaped tube group, endotracheal tube will be molded to a shape similar to the blade of the videolaryngoscope (McGrath MAC®). In the 60-degrees-curved tube group, endotracheal tube will be bent 60 degrees. Time to intubation, intubation attempts and ease of intubation wil be assessed.

Study Type

Interventional

Enrollment (Actual)

222

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for the surgery under general anesthesia
  • Adult patients from 18 years to 65 years
  • American society of Anesthesiologist physical status 1,2,3

Exclusion Criteria:

  • Previously diagnosed for the difficult intubation
  • Pregnancy
  • Obesity (Body mass index over 40 g/m^2)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: J-shaped
Endotracheal tube will be molded into a J-shape that is similar to that of Macintosh type blade of a McGrath MAC® videolaryngoscope.
Device: J shaped stylet used for endotracheal intubation
After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.
Active Comparator: 60-degrees
Endotracheal tube will be bent 60 degrees.
Device: 60-degrees stylet used for endotracheal intubation
After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to intubate
Time Frame: 20 minutes after induction started.
the time took from the blade passing through the incisor teeth of the patient to the first end tidal CO2 appears on the anesthesia monitor screen.
20 minutes after induction started.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of intubation attempts
Time Frame: 20 minutes after induction started.
numbers of attempts for the successful endotracheal intubation
20 minutes after induction started.
Level of difficulty in intubation
Time Frame: 20 minutes after induction started.
easy, moderate, difficult
20 minutes after induction started.

Collaborators and Investigators

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

Sponsor

Eunah Cho, MD

Investigators

  • Principal Investigator: Hyunyoung Lim, M.D., Hanyang 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 (Actual)

May 28, 2018

Primary Completion (Actual)

July 4, 2018

Study Completion (Actual)

July 4, 2018

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-01-033-001
  • 2018-01-016-003 (Other Identifier: Hanyang university hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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