Clinical trial NCT04226703: Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway
Official title: The Role of Indirect Laryngoscopy, Clinical and Ultrasonographic Assessment in Prediction of Difficult Airway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Intubation
Keywords: airway
laryngoscopy
ultrasonography
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cormack-Lehane Classification
timeFrame: Three minutes after induction of anesthesia.
measure: Epiglottis skin distance in centimeters.
timeFrame: Five minutes before induction of anesthesia.
measure: Hyoid bone-skin distance in centimeters.
timeFrame: Five minutes before induction of anesthesia.
measure: Anterior commissure-skin distance in centimeters.
timeFrame: Five minutes before induction of anesthesia.
measure: Thickness of tongue root in centimeters.
timeFrame: Five minutes before induction of anesthesia.
measure: Indirect Laryngoscopic Grade
timeFrame: The day before surgery
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: The day before surgery
measure: Thyromental distance in centimeters
timeFrame: The day before surgery
measure: Sternomental distance in centimeters.
timeFrame: The day before surgery
measure: Neck circumference in centimeters.
timeFrame: The day before surgery
measure: Mallampati classification
timeFrame: The day before surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul University
name: Bora Başaran
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.