Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway

NCT04226703 | Completed

• 1 other identifier: 2019/722
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Intubation

Keywords

airway; laryngoscopy; ultrasonography

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Body mass index (BMI)

  The day before surgery

• Thyromental distance in centimeters

  The day before surgery

• Sternomental distance in centimeters.

  The day before surgery

• Neck circumference in centimeters.

  The day before surgery

• Mallampati classification

  The day before surgery

Study Arms (1)

Study group

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

Diagnostic Test: Ultrasonographic upper airway measurements

Interventions

Ultrasonographic upper airway measurements DIAGNOSTIC_TEST

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)

Also known as: Indirect Laryngoscopy

Study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject is operated in ear, nose and throat department.
• Subject over the age of 18.
• Subject giving consent to participate in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related 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.

  PMID: 29109635 BACKGROUND

• 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.

  PMID: 22425162 BACKGROUND

Study Officials

• Bora Başaran

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: June 15, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 15, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

TU (1)