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Completed

NCT Number: NCT04226703

Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway

This study was designed to assess the success of indirect laryngoscopy and ultrasonographic measurements in the prediction of difficult airway. All patients were examined by indirect laryngoscopy and ultrasonography preoperatively and the predictive values for difficult airway of these methods were compared.

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Key information

Conditions

Difficult Intubation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

About this study

Difficult airway is a condition that increases the patient's vital risk and leaves the anesthesia and surgical team in a difficult position. Failure to perform an adequate preoperative evaluation may result in the team being unprepared. Therefore, various methods have been investigated in the prediction of difficult airway from past to present. With the development of technology, imaging methods have become routine applications in clinical use. Ultrasonography and indirect laryngoscopy have been shown to be used in predicting difficult airway in the literature, but there is no study showing which is a better predictor.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is operated in ear, nose and throat department.
  • Subject over the age of 18.
  • Subject giving consent to participate in the study.

Exclusion criteria

  • Subject under the age of 18
  • Subject with a history of radiotherapy in the head and neck region,
  • Subject with facial deformity,
  • Subject whose neck movements have been restricted by previous trauma or surgery,
  • Subject has laryngeal disease
  • Previously operated subject with known airway assessment
  • Morbidly obese subject with BMI> 40

Treatment and study plan

Ultrasonographic upper airway measurements

Diagnostic Test

Ultrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge root.

Indirect Laryngoscopy: Grading of laryngoscopic view (I=Visible anterior commissure and vocal cords, II= visible posterior part of vocal cords and posterior commissure, III= Visible posterior commissure and epiglottis, IV= Visible only epiglottis tip and posterior pharyngeal wall)

Other names: Indirect Laryngoscopy

Primary outcomes

  1. Cormack-Lehane Classification

    Time frame: Three minutes after induction of anesthesia.

    The anesthesiologist, who is blind about indirect laryngoscopy findings and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.

  2. Epiglottis skin distance in centimeters.

    Time frame: Five minutes before induction of anesthesia.

    The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures epiglottis to skin distance.

  3. Hyoid bone-skin distance in centimeters.

    Time frame: Five minutes before induction of anesthesia.

    The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures hyoid bone to skin distance.

  4. Anterior commissure-skin distance in centimeters.

    Time frame: Five minutes before induction of anesthesia.

    The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures anterior commissure to skin distance.

  5. Thickness of tongue root in centimeters.

    Time frame: Five minutes before induction of anesthesia.

    The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures thickness of tongue root.

  6. Indirect Laryngoscopic Grade

    Time frame: The day before surgery

    The otolaryngologist,who is blind about ultrasonographic airway measurements of patients, performs indirect laryngoscopy and evaluates the laryngeal view.

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: The day before surgery

    Weight and height will be combined to report BMI in kg/m^2.Evaluated by the anesthesiologist who performs intubation.

  2. Thyromental distance in centimeters

    Time frame: The day before surgery

    The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.

  3. Sternomental distance in centimeters.

    Time frame: The day before surgery

    The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.

  4. Neck circumference in centimeters.

    Time frame: The day before surgery

    Evaluated by the anesthesiologist who performs intubation.

  5. Mallampati classification

    Time frame: The day before surgery

    Evaluated by the anesthesiologist who performs intubation.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2020
Registry last updated
Jan 13, 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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