Role of Ultrasonography in Airway Management

October 24, 2019 updated by: başak gülel, Diskapi Yildirim Beyazit Education and Research Hospital

Is There a Role for Ultrasonography in the Airway Management of Patients With Obesity

Ultrasound is one of the most useful devices in daily anesthesia practice. Latest purpose of ultrasound usage is prediction of difficult intubation. In this study, we aimed to predict difficult laryngoscopy and intubation by using ultrasound measurement of neck soft tissue thickness in obese patient preoperatively.

Study Overview

Status

Unknown

Conditions

Detailed Description

In this prospective and randomized controlled study, mallampati scores, interincisor gap, thyromental distance, neck circumference measurement and upper lip bite test scores will be recorded in sixty obese patients.

Additionally, neck tissue thickness will be recorded at 4 different levels (hyoid bone-skin distance, epiglot-skin distance , thyroid istmus-skin distance, vocal cord-skin distance) after the sniffing position by ultrasound with the linear probe. All measurements will be repeated three times and an average values will be recorded.

After all this measurements, endotracheal intubation will be performed by an experienced anesthetist who is uninformed about study. During intubation the Cormack Lehane (C/L, grade 1: full view of the vocal cords; grade 2a: partial view of the glottis; 2b: posterior part of the vocal cord and arytenoids visible; grade 3: only epiglottis visible; and grade 4: neither epiglottis nor glottis visible) and the Intubation Difficulty Scale (IDS) score (the numbers of attempts, operators, and alternative techniques used, the C/L grade of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords. Every insertion of the laryngoscope and advancement of the tracheal tube towards the glottis counted as an attempt. A score of >5 indicates moderate-to-major difficulty) will be recorded.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

    • Province
      • Ankara, Province, Turkey, 06080
        • Başak Gülel

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with obesity body mass index >30 undergoing surgery and requiring tracheal intubation

Description

Inclusion Criteria:

  • BMI>30
  • 18-65 YEARS
  • ASA 1-2-3
  • Obese patients

Exclusion Criteria:

  • Pregnancy
  • Upper airway pathology
  • Cervical spine pathology
  • Laryngeal pathology

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyoid bone-skin distance -effect of ultrasound on prediction of difficult laryngoscopy
Time Frame: 30 minutes before induction
The hyoid bone-skin distance will be measured by using ultrasound in centimeters
30 minutes before induction
Epiglottis-skin distance
Time Frame: 30 minutes before induction
The epiglottis-skin distance will be measured by using ultrasound in centimeters
30 minutes before induction
Thyroid isthmus-skin distance
Time Frame: 30 minutes before induction
The thyroid isthmus-skin distance will be measured by using ultrasound in centimeters
30 minutes before induction
Vocal cord-skin distance
Time Frame: 30 minutes before induction
The vocal cord-skin distance will be measured by using ultrasound in centimeters
30 minutes before induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation difficulty scale score
Time Frame: 1 minutes after intubation
Each number of numbers attempt, operator and alternative techniques used, the Cormack Lehane score of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords count 1 point. A score of >5 indicates moderate-to-major difficulty
1 minutes after intubation

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Basak Gulel, Sbü Dışkapı Yıldırım Beyazıt Eğitim Ve Araştırma Hastanesi

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.

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 (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BasakUltrasonografi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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