Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway

Completed

• Conditions: Difficult Intubation
• Interventions: Diagnostic Test: Ultrasonographic upper airway measurements

• Registration Number: NCT04226703
• Lead Sponsor: Istanbul University

Brief Summary

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.

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 Timeline

• Study Start: 2019-06-15
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-15
• Status Verified: 2020-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Ultrasonographic upper airway measurements	Patients over the age of 18 who underwent surgery in the ear, nose and throat department.

Primary Outcome Measures

Name	Time	Method
Thickness of tongue root in centimeters.	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.
Indirect Laryngoscopic Grade	The day before surgery	The otolaryngologist,who is blind about ultrasonographic airway measurements of patients, performs indirect laryngoscopy and evaluates the laryngeal view.
Cormack-Lehane Classification	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.
Epiglottis skin distance in centimeters.	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.
Hyoid bone-skin distance in centimeters.	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.
Anterior commissure-skin distance in centimeters.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul University, Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey