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CompletedNCT02988336Updated Jan 31, 2017

TMHT - New Method of Difficult Intubation Prediction

An observational study in Airway Management and Predictive Value of Tests, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-31.

Sponsored by Medical University of Silesia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
237
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

Proper prediction of the occurrence of difficult intubation plays a crucial role in anaesthesiology. For years attempts have been made to develop methods allowing anaesthesiologists to correctly predict the occurrence of difficult intubation. None of the currently used tests and anthropometric measurements present satisfying predictive value. Recent studies show promise in Thyromental Height Test (TMHT), which base on the height between the anterior borders of the mentum and the thyroid cartilage, measured while the patient lies in the supine position with closed mouth, as a single, non-invasive predictor of difficult intubation. Use of double lumen endotracheal tubes during thoracic procedures, due to greater diameter of the tube, may lead to higher occurrence of difficult intubation. That is why, the purpose of this study is to assess the usefulness of the TMHT in prediction of difficult intubation using double lumen endotracheal tubes in patients scheduled for elective thoracic procedures and relate it to other, commonly used predictive tests.

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

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Conditions studied

  • Airway Management
  • Predictive Value of Tests

Keywords

  • difficult intubation
  • thyromental height
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In context

Lead sponsor

Medical University of Silesia is the lead sponsor of 111 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • patients scheduled for elective thoracic procedures, requiring general anaesthesia, direct laryngoscopy and intubation with a Robertshaw type double lumen endotracheal tubes
  • consent for participation in the trail
  • older than 18

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
237 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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, measured during routine preoperative anaesthetic visit.

    Time frame: immediate

Secondary outcomes

  1. 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.

    Time frame: immediate

  2. 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.

    Time frame: immediate

  3. 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.

    Time frame: immediate

  4. score in Cormack-Lehane scale

    During direct laryngoscopy the patient is graded in Cormack-Lehane Scale by the laryngoscopist.

    Time frame: immediate

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Study locations

1 site
  • Samodzielny Publiczny Szpital Kliniczny nr 1
    Zabrze, Silesia 41-800, Poland
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References and documents

Publications

  • Palczynski P, Bialka S, Misiolek H, Copik M, Smelik A, Szarpak L, Ruetzler K. Thyromental height test as a new method for prediction of difficult intubation with double lumen tube. PLoS One. 2018 Sep 13;13(9):e0201944. doi: 10.1371/journal.pone.0201944. eCollection 2018. PubMed 30212462 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02988336
Lead sponsor
Medical University of Silesia
Responsible party
Piotr Palaczyński (Principal Investigator, Medical University of Silesia) — Principal investigator
First posted
Dec 9, 2016
Start date
Sep 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jan 31, 2017

Study contacts

Hanna Misiołek, MD PhD
study chair · School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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