TMHT - New Method of Difficult Intubation Prediction

Sponsor
Medical University of Silesia (Other)
Overall Status
Completed
CT.gov ID
NCT02988336
Collaborator
(none)
237
1
4
59.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    237 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Thyromental Height Test as a New Method for Prediction of Difficult Intubation With Double Lumen Tube
    Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Jan 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Thyromental height [immediate]

      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.

    Secondary Outcome Measures

    1. Thyromental distance [immediate]

      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.

    2. Sternomental distance [immediate]

      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.

    3. score in modified Mallampati test [immediate]

      The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.

    4. score in Cormack-Lehane scale [immediate]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    • emergency procedures

    • visible anatomic abnormalities

    • patients scheduled for awake fibre optic intubation

    • lack of consent for participation in the trail

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samodzielny Publiczny Szpital Kliniczny nr 1 Zabrze Silesia Poland 41-800

    Sponsors and Collaborators

    • Medical University of Silesia

    Investigators

    • Study Chair: Hanna Misiołek, MD PhD, School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Piotr Palaczyński, Principal Investigator, Medical University of Silesia
    ClinicalTrials.gov Identifier:
    NCT02988336
    Other Study ID Numbers:
    • TMHT-01
    First Posted:
    Dec 9, 2016
    Last Update Posted:
    Jan 31, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Piotr Palaczyński, Principal Investigator, Medical University of Silesia

    Study Results

    No Results Posted as of Jan 31, 2017