Clinical trial NCT03647371: TMHT - Difficult Intubation Prediction Using Videolaryngoscopy
Official title: Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Videolaryngoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Predictive Value of Tests
Intubation
Keywords: Difficult Intubation
Thyromental Height Test
Videolaryngoscopy
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Successful and fast intubation are crucial for the safety of general anaesthesia. Failed intubation and acute hypoxia remain among the major contributing factors of anaesthesia related deaths. Difficult intubation prevalence in literature is very inconsistent and varies between 1.5-20% of cases in general population, to even 50% in obese Thai population.

There is a number of anthropometric scales and tests used for predicting difficult intubation. However, none of them appears to be sensitive and specific enough to effectively predict difficult intubation.

Recently, simple and non-invasive test predicting difficult intubation was introduced-thyromental height test (TMHT). It shows promise as a more effective substitution for frequently cited anthropometric measures. 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 videolaryngoscopy and double lumen endotracheal tubes in patients scheduled for elective thoracic surgical procedures. The secondary aim is to evaluate usefulness of other commonly used predictive tests associated with difficult intubation.

During routine, preoperative anaesthetic visit thyromental height, thyromental distance, sternomental distance and Mallampati scale score are assessed. Then, during videolaryngoscopy and intubation, score in Cormack-Lehane scale and occurrence of difficult intubation are noted.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective thoracic procedures, requiring general anaesthesia, videolaryngoscopy and intubation with a Robert-Shaw type 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: From August 6 2018 to August 5 2019.
Secondary outcomes:
measure: score in Cormack-Lehane scale
timeFrame: From August 6 2018 to August 5 2019.
measure: Thyromental distance
timeFrame: From August 6 2018 to August 5 2019.
measure: Sternomental distance
timeFrame: From August 6 2018 to August 5 2019.
measure: core in modified Mallampati test
timeFrame: From August 6 2018 to August 5 2019.
measure: distance of mouth opening
timeFrame: From August 6 2018 to August 5 2019.
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: