Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Difficult Intubation and Tongue Protrusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679027
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Alkin Colak, Trakya University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Difficult Intubation, Tongue Mobility Other: Protrude tongue maximally and upward (PTMU) Other: Protrude tongue maximally and downward (PTMD) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements
Study Start Date : January 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: Easy intubation
Intubation difficulty score <5
Other: Protrude tongue maximally and upward (PTMU)
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).

Other: Protrude tongue maximally and downward (PTMD)
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
Other: Protrude tongue maximally and upward (PTMU)
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).

Other: Protrude tongue maximally and downward (PTMD)
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).




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Layout table for additonal information
Responsible Party: Alkin Colak, Associate professor, Trakya University
ClinicalTrials.gov Identifier: NCT02679027    
Other Study ID Numbers: tongueintubation
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016