TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes

Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Double Lumen Video Tubes

The purpose of this study is to assess the usefulness of the Thyromental Height Test in prediction of difficult intubation and the utility of double lumen video endotracheal tubes in patients scheduled for elective thoracic procedures.

Study Overview

• Status: Completed
• Conditions: Predictive Value of Tests; Intubation;Difficult
• Intervention / Treatment: Device: Double Lumen Endotracheal Tube.; Device: Double Lumen Video Endotracheal Tube.

Detailed Description

Most of the thoracic surgery interventions require lung isolation techniques. Currently the most commonly used lung isolation techniques are double lumen tubes or single lumen tubes with additional use of bronchial blockers. In both cases fiberoptic bronchoscopy is used for proper placement and maintenance during operation. Recently double lumen video endotracheal tubes were proposed as a new alternative for lung isolation techniques. The double lumen video endotracheal tube differs significantly in size and physical characteristics from standard single lumen endotracheal tube and intubation may prove to be challenging even for an experienced practitioner. Therefore proper prediction of difficult intubation play a crucial role in a clinical setting. Sensitivity and specificity of existing anthropometric scales and tests used for prediction of difficult intubation seem lacking so new methods such as Thyromental Height Test (TMHT) are being introduced. It is based on the height between the anterior border of the thyroid cartilage and the anterior border of the mentum, measured while the patient lies in the supine position with closed mouth. The main objective of the trial is to assess the clinical usefulness of TMHT in prediction of difficult intubation using double lumen video endotracheal tubes in patients scheduled for elective thoracic surgical procedures. The secondary aim is to evaluate the utility of double lumen video endotracheal tubes as a novel method of lung separation.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Poland
  • Silesia
    • Zabrze, Silesia, Poland, 41-800
      • Samodzielny Publiczny Szpital Kliniczny nr 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing elective thoracic procedures in university hospital, requiring general anaesthesia and intubation with a double lumen endotracheal tubes.

Description

Inclusion Criteria:

• patients scheduled for elective thoracic procedures, requiring general anaesthesia and intubation with double lumen endotracheal tubes
• written, informed consent for participation in the trail
• older than 18 years

Exclusion Criteria:

• emergency procedures
• visible anatomic abnormalities
• patients scheduled for awake fibre optic intubation
• lack of consent for participation in the trail

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Double Lumen Endotracheal Tube; Group of patients intubated with Double Lumen Endotracheal Tube.	Device: Double Lumen Endotracheal Tube.; Intubation was performed with Double Lumen Endotracheal Tube.
Double Lumen Video Endotracheal Tube; Group of patients intubated with Double Lumen Video Endotracheal Tube.	Device: Double Lumen Video Endotracheal Tube.; Intubation was performed with Double Lumen Video Endotracheal Tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyromental height	The height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible), in supine position with mouth closed, measured with a depth gauge during routine preoperative anaesthetic visit.	Preoperative (1 day prior to the operation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Intubation	Time of intubation defined as a time from direct laryngoscopy to proper placement of double lumen endotracheal tube measured with a timer during induction of general anesthesia.	Intraoperatively
Airway trauma	During fiberoptic bronchoscopy after the operation airway trauma on the level of bronchus, tracheal bifurcation, trachea and vocal cords were reported, where 0 was defined as no visible trauma, 1 as a redness, 2 as oedema, 3 as hematoma and 4 as active bleeding.	Intraoperative
Usage of fiberoptic bronchoscopy	Usage of fiberoptic bronchoscopy for proper placement of double lumen tube was noted.	Intraoperatively
score in Cormack-Lehane scale	During direct laryngoscopy the laryngeal view is graded in Cormack-Lehane Scale by the laryngoscopist. Grade I is assigned when the glottis is fully visible, grade II when the glottis is partially visible, grade III when only the epiglottis is visible and grade IV when neither glottis nor epiglottis is visible.	Preoperative (1 day prior to the operation)
Thyromental distance	The distance between the thyroid prominence and the most anterior part of the mental prominence of the mandible, measured with a standard centigrade ruler as the distance in centimetres with the patient in supine position, head fully extended, mouth closed, during routine preoperative anaesthetic visit.	Preoperative (1 day prior to the operation)
Sternomental distance	The distance in centimetres between the superior border of the manubrium sterni and the bony point of the mentum, with the patient in supine position, head fully extended, mouth closed, measured with a standard centigrade ruler, during routine preoperative anaesthetic visit.	Preoperative (1 day prior to the operation)
score in modified Mallampati test	The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.	Preoperative (1 day prior to the operation)

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Investigators: Study Director: Hanna Misiołek, MD PhD, Medical University of Silesia; Study Chair: Szymon Białka, MD, Medical University of Silesia

Publications and helpful links

General Publications

• Palaczynski P, Misiolek H, Bialka S, Owczarek AJ, Gola W, Szarpak L, Smereka J. A randomized comparison between the VivaSight double-lumen tube and standard double-lumen tube intubation in thoracic surgery patients. J Thorac Dis. 2022 Oct;14(10):3903-3914. doi: 10.21037/jtd-22-451.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: September 22, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Difficult Intubation; Thyromental Height Test; Double Lumen Video Tube
• Other Study ID Numbers: TMHT-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No