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Completed

NCT Number: NCT04289597

Evaluation of Difficult Airway With Ultrasonography

As a result of anatomical and physiological changes in obese patients, airway management can be challenging. Ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. In this study we planned to evaluate the measurement of neck anterior soft tissues by ultrasound in obese patients before anesthesia induction to anticipate difficult mask ventilation, difficult laryngoscopy, and intubation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskisehir Osmangazi Univercty

Odunpazari, Eskişehir, 26040, Turkey (Türkiye)

About this study

Patients with BMI> 30, schedule elective surgery under general anesthesia, and give consent will be included in the study. In the preoperative evaluation, demographic data of the patients, airway physical examination results (mouth opening, Mallampati score, thyromental distance, neck circumference (from thyroid cartilage level), abnormal upper tooth presence, neck movement restriction], presence of sleep apnea and STOP-BANG score will be recorded. In the patients taken on the operation table with supine position, ultrasound-guided soft tissue distances will be measured using ultrasound 6-13 Hz linear probe. The distance between the hyoid bone-skin (DSHB), the vocal cord anterior commissura-skin distance (DSAC), the minimum distance of the trachea to the skin at the level of the suprasternal notch (DST), the distance between the thyroid isthmus and the skin (DSI), and the distance between the epiglottis and the skin (DSE) will be measured and recorded. After standard monitoring and anesthesia induction, difficult mask ventilation will be evaluated with Han Scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation. Difficult laryngoscopy will be evaluated with Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy. Difficult intubation will also be evaluated with the number and duration of intubation attempts with the Macintosh blade. Tracheal intubation will be performed by an anesthesiologist who has at least two years of experience and unaware of ultrasound measurements. The duration of intubation (the time from the first handling of the laryngoscope until the capnography trace appeared) and the number of trials will be recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients planned to undergo general anesthesia for elective surgery
  • American Anesthesiology Association physical classification (ASA) status I-III
  • Body mass index (BMI) above 30

Exclusion criteria

  • Patients with neck mass
  • History of previous neck and thyroid surgery, trauma, arthritis, loss of teeth
  • History of difficult intubation
  • Bearded patients
  • Pregnant women

Treatment and study plan

Distance between hyoid bone-skin (DSHB)

Diagnostic Test

Distance between hyoid bone-skin

Other names: DSHB

Vocal cord anterior commissura-skin distance (DSAC)

Diagnostic Test

Vocal cord anterior commissura-skin distance

Other names: DSAC

minimum distance of the trachea to the skin at the level of suprasternal notch

Diagnostic Test

Distance of the trachea to the skin at the level of suprasternal notch

Other names: DST

Thyroid isthmus-skin distance (DSI)

Diagnostic Test

Thyroid isthmus-skin distance

Other names: DSI

Skin-epiglottic distance (DSE)

Diagnostic Test

Skin-epiglottic distance

Other names: DSE

Primary outcomes

  1. Difficult Mask Ventilation

    Time frame: ''1 minute'' (During anesthesia induction)

    Difficult mask ventilation will be evaluated with Han scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation.

Secondary outcomes

  1. Difficult laryngoscopy

    Time frame: ''1 minute''

    Difficult laryngoscopy will be evaluated Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy.

  2. Difficult intubation

    Time frame: ''1 minute''

    Total number of intubation attempts

  3. The duration of endotracheal intubation time

    Time frame: 1 minute

    The time from the first handling of the laryngoscope until the capnography trace appeared

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Evaluation of Difficult Airway in Obese Patients With Ultrasonography

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Mar 14, 2022

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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