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Completed

NCT Number: NCT04101734

TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, 41-800, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double Lumen Endotracheal Tube.

Device

Intubation was performed with Double Lumen Endotracheal Tube.

Double Lumen Video Endotracheal Tube.

Device

Intubation was performed with Double Lumen Video Endotracheal Tube.

Primary outcomes

  1. Thyromental height

    Time frame: Preoperative (1 day prior to the operation)

    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 outcomes

  1. Time of Intubation

    Time frame: Intraoperatively

    Time of intubation defined as a time from direct laryngoscopy to proper placement of double lumen endotracheal tube measured with a timer during induction of general anesthesia.

  2. Airway trauma

    Time frame: Intraoperative

    During fiberoptic bronchoscopy after the operation airway trauma on the level of bronchus, tracheal bifurcation, trachea and vocal cords were reported, where 0 was defined as no visible trauma, 1 as a redness, 2 as oedema, 3 as hematoma and 4 as active bleeding.

  3. Usage of fiberoptic bronchoscopy

    Time frame: Intraoperatively

    Usage of fiberoptic bronchoscopy for proper placement of double lumen tube was noted.

  4. score in Cormack-Lehane scale

    Time frame: Preoperative (1 day prior to the operation)

    During direct laryngoscopy 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.

  5. Thyromental distance

    Time frame: Preoperative (1 day prior to the operation)

    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.

  6. Sternomental distance

    Time frame: Preoperative (1 day prior to the operation)

    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.

  7. score in modified Mallampati test

    Time frame: Preoperative (1 day prior to the operation)

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

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Double Lumen Video Tubes

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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