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TMHT - Difficult Intubation Prediction Using Videolaryngoscopy

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ClinicalTrials.gov Identifier: NCT03647371
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Piotr Palaczyński, Medical University of Silesia

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.

Condition or disease Intervention/treatment Phase
Predictive Value of Tests Intubation Procedure: Macintosh laryngoscopy Procedure: McGrath MAC video laryngoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Videolaryngoscopy
Actual Study Start Date : August 6, 2018
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 5, 2019

Arm Intervention/treatment
Macintosh laryngoscope
direct laryngoscope - laryngoscope with Macintosh blade
Procedure: Macintosh laryngoscopy
intubation with MAcintosh laryngoscopy after anesthetic induction

McGrath videolaryngoscope
McGrath Videolaryngoscope
Procedure: McGrath MAC video laryngoscopy
intubation with McGrath MAC videolaryngoscopy after anesthetic induction




Primary Outcome Measures :
  1. Thyromental height [ Time Frame: From August 6 2018 to August 5 2019. ]
    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.


Secondary Outcome Measures :
  1. score in Cormack-Lehane scale [ Time Frame: From August 6 2018 to August 5 2019. ]
    During videolaryngoscopy 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.

  2. Thyromental distance [ Time Frame: From August 6 2018 to August 5 2019. ]
    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.

  3. Sternomental distance [ Time Frame: From August 6 2018 to August 5 2019. ]
    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.

  4. core in modified Mallampati test [ Time Frame: From August 6 2018 to August 5 2019. ]
    The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.

  5. distance of mouth opening [ Time Frame: From August 6 2018 to August 5 2019. ]
    Measured as a distance between the lower and upper incisors with a tape measure (Standard, Hoechstmas, Sulzbach, Germany) as a distance in centimetres. Patients are in sitting position with mouth maximally opened, tongue retracted and without phonation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647371


Locations
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Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Zabrze, Silesia, Poland, 41-800
Sponsors and Collaborators
Medical University of Silesia
Investigators
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Study Director: Hanna Misiołek, MD PhD Medical University of Silesia
Study Chair: Szymon Białka, MD Medical University of Silesia

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Responsible Party: Piotr Palaczyński, Principal Investigator, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03647371    
Other Study ID Numbers: TMHT-03
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Piotr Palaczyński, Medical University of Silesia:
Difficult Intubation
Thyromental Height Test
Videolaryngoscopy