Difficult Intubation and Tongue Protrusion

August 15, 2016 updated by: Alkin Colak, Trakya University

New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements

Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.

Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.

To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.

Study Overview

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Not Applicable

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing abdominal surgery with general anesthesia
  • Able to sit

Exclusion Criteria:

  • Enable to sit,
  • Patients had head or neck surgery,
  • Patients with unstable cardiological and respiratory hemodynamic symptoms,
  • Dental prosthesis

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Easy intubation
Intubation difficulty score <5
The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU).
The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD).
Active Comparator: Difficult intubation
Intubation difficulty score >5
The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU).
The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation difficulty scale
Time Frame: 2 days
Intubation difficulty scale score includes 7 variables for difficult intubation. N1: The number of attempts for intubation (for the first attempt 0 point, for the other attempts 1 point each); N2: The number of anesthesiologist for the laryngoscopies (for the first attempt 0 point, for the other attempts 1 point each); N3: Alternative intubation techniques that are used (if not needed 0 point, change of blade type or using blind nasotracheal intubation 1 point each); N4: 1 point less than Cormack and Lehane Classification for defining glottic exposure; N5: The degree of force of lifting laryngoscopy (normal lifting 0 point, more force needed 1 point); N6: Using external laryngeal pressure 1 point; N7: The view of the vocal cords (abduction position 0 point, adduction position 1 point). A score of 0-4 defines easy intubation and an IDS score ≥5 defines difficult intubation
2 days

Collaborators and Investigators

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

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

January 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • tongueintubation

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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