Evaluation of Difficult Airway With Ultrasonography

March 11, 2022 updated by: Meryem Onay, Eskisehir Osmangazi University

Evaluation of Difficult Airway in Obese Patients 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Eskisehir
      • Odunpazarı, Eskisehir, Turkey, 26040
        • Eskisehir Osmangazi Univercty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A hundred twenty-eight patients, aged 18-65 years-old, with an American Anesthesiology Association physical classification (ASA) I-III and body mass index (BMI) above 30 and planned to undergo general anesthesia for elective surgery, will be included in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese patients
Obese patients with BMI>30
Diagnostic test: Distance between hyoid bone-skin (DSHB)
Distance between hyoid bone-skin
Other Names:
  • DSHB
Diagnostic test: Vocal cord anterior commissura-skin distance (DSAC)
Vocal cord anterior commissura-skin distance
Other Names:
  • DSAC
Diagnostic test: minimum distance of the trachea to the skin at the level of suprasternal notch
Distance of the trachea to the skin at the level of suprasternal notch
Other Names:
  • DST
Diagnostic test: Thyroid isthmus-skin distance (DSI)
Thyroid isthmus-skin distance
Other Names:
  • DSI
Diagnostic test: Skin-epiglottic distance (DSE)
Skin-epiglottic distance
Other Names:
  • DSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
''1 minute'' (During anesthesia induction)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
''1 minute''
Difficult intubation
Time Frame: ''1 minute''
Total number of intubation attempts
''1 minute''
The duration of endotracheal intubation time
Time Frame: 1 minute
The time from the first handling of the laryngoscope until the capnography trace appeared
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Investigators

  • Principal Investigator: Meryem Onay, MD, Teaching Assistant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2020

Primary Completion (ACTUAL)

March 11, 2022

Study Completion (ACTUAL)

March 11, 2022

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ESOGU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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