Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway

The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment 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.

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Diagnostic test: Ultrasonographic upper airway measurements

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University, Istanbul Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients who apply to ear, nose and throat department for any kind of otorhinolaryngological operation are included into the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; Patients over the age of 18 who underwent surgery in the ear, nose and throat department.

Diagnostic test: Ultrasonographic upper airway measurements; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cormack-Lehane Classification	The anesthesiologist, who is blind about indirect laryngoscopy findings and ultrasonographic airway measurements, performs intubation and evaluates the laryngeal view.	Three minutes after induction of anesthesia.
Epiglottis skin distance in centimeters.	The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures epiglottis to skin distance.	Five minutes before induction of anesthesia.
Hyoid bone-skin distance in centimeters.	The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures hyoid bone to skin distance.	Five minutes before induction of anesthesia.
Anterior commissure-skin distance in centimeters.	The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures anterior commissure to skin distance.	Five minutes before induction of anesthesia.
Thickness of tongue root in centimeters.	The anesthesiologist, who is blind about indirect laryngoscopy findings and is experienced user of ultrasonography, measures thickness of tongue root.	Five minutes before induction of anesthesia.
Indirect Laryngoscopic Grade	The otolaryngologist,who is blind about ultrasonographic airway measurements of patients, performs indirect laryngoscopy and evaluates the laryngeal view.	The day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mallampati classification	Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Neck circumference in centimeters.	Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Sternomental distance in centimeters.	The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Thyromental distance in centimeters	The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.Evaluated by the anesthesiologist who performs intubation.	The day before surgery

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Bora Başaran, Istanbul University

Publications and helpful links

General Publications

• Parameswari A, Govind M, Vakamudi M. Correlation between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients: A prospective study. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):353-358. doi: 10.4103/joacp.JOACP_166_17.
• Sanchez-Morillo J, Estruch-Perez MJ, Hernandez-Cadiz MJ, Tamarit-Conejeros JM, Gomez-Diago L, Richart-Aznar M. Indirect laryngoscopy with rigid 70-degree laryngoscope as a predictor of difficult direct laryngoscopy. Acta Otorrinolaringol Esp. 2012 Jul-Aug;63(4):272-9. doi: 10.1016/j.otorri.2012.01.007. Epub 2012 Mar 17. English, Spanish.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2019
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ultrasonography; laryngoscopy; airway
• Other Study ID Numbers: 2019/722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No