Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway

Difficult Intubation Clinical Trial

Official title:

The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226703
• Other study ID #: 2019/722
• Status: Completed
• Start date: June 15, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: January 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 15, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

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)

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Sánchez-Morillo J, Estruch-Pérez MJ, Hernández-Cádiz MJ, Tamarit-Conejeros JM, Gómez-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. Epub 2012 Mar 17. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	Thyromental distance in centimeters	The distance between thyroid notch and mentum. Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	Sternomental distance in centimeters.	The distance between sternal notch and mentum. Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	Neck circumference in centimeters.	Evaluated by the anesthesiologist who performs intubation.	The day before surgery
Secondary	Mallampati classification	Evaluated by the anesthesiologist who performs intubation.	The day before surgery