Clinical trial NCT04101734: TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes
Official title: Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Double Lumen Video Tubes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Predictive Value of Tests
Intubation;Difficult
Keywords: Difficult Intubation
Thyromental Height Test
Double Lumen Video Tube
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thyromental height
timeFrame: Preoperative (1 day prior to the operation)
Secondary outcomes:
measure: Time of Intubation
timeFrame: Intraoperatively
measure: Airway trauma
timeFrame: Intraoperative
measure: Usage of fiberoptic bronchoscopy
timeFrame: Intraoperatively
measure: score in Cormack-Lehane scale
timeFrame: Preoperative (1 day prior to the operation)
measure: Thyromental distance
timeFrame: Preoperative (1 day prior to the operation)
measure: Sternomental distance
timeFrame: Preoperative (1 day prior to the operation)
measure: score in modified Mallampati test
timeFrame: Preoperative (1 day prior to the operation)
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
state: Silesia
Study officials:
affiliation: Medical University of Silesia
name: Hanna Misiołek, MD PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Silesia
name: Szymon Białka, MD
role: STUDY_CHAIR
References:
citation: 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.