Midsagittal Tongue Measurement to Predict Difficult Airways

Ultrasonography Clinical Trial

Official title:

Efficacy of Midsagittal Tongue Cross-section Area Measured by Ultrasound in Predicting Difficult Airway in Obesity Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519358
• Other study ID #: SKara
• Status: Completed
• Start date: September 13, 2022
• Est. completion date: March 25, 2024

Study information

• Verified date: May 2024
• Source: Samsun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An unanticipated difficult airway is a potentially life-threatening event during elective surgery or management of critical conditions. However, the common clinical screening tests, show low sensitivity and specificity with a limited predictive value. Recently, ultrasound has been used to identify difficult airway. Tongue volume is one of the parameters evaluated by ultrasound. In this study, we aim to evaluate the capacity of mid-sagittal tongue CSA and tongue width to predict difficult laryngoscopy and difficult intubation.

Description:

Anatomical changes that adversely affect airway accessibility due to increased adipose tissue in obese patients make it difficult to establish an advanced airway by orotracheal intubation. Difficulty with airway management for anesthesia has potentially serious implications, as failure to secure a patent airway can result in hypoxic brain injury or death in a matter of minutes. There have been no effective methods to predict difficult airways accurately. Ultrasonography is a non-invasive, safe, and painless modality for evaluating soft tissues. In recent years, studies have been carried out on the parameters that can be used in determining the difficult airway with ultrasound. These include the distance from the skin to the epiglottis, the tongue thickness, the tongue volume, the mandibular condylar mobility, and the visibility of the hyoid. Few studies have whether midsagittal tongue cross section area and tongue width can also be used to predict difficult airways similarly to tongue volume. Therefore, this study was designed to evaluate the predictive value of accurately measured tongue thickness and cross-sectional tongue area using ultrasonography for predicting difficult tracheal intubation and difficult laryngoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 25, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical condition I-II-III

• Patients are required general anesthesia with tracheal intubation for bariatric surgery.

Exclusion Criteria:

• Patients with maxillofacial deformity, trauma, or tumor

• Patients with identified difficult airway or difficult airway history

• Patients with cancellation of tracheal intubation for a non-difficult airway reason

Related Conditions & MeSH terms

• Difficult Airway
• Ultrasonography

Locations

Country	Name	City	State
Turkey	Samsun University Faculty of medicine	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989. — View Citation

Moura ECR, Filho ASM, de Oliveira EJSG, Freire TT, da Cunha Leal P, de Sousa Gomes LMR, Servin ETN, de Oliveira CMB. Comparative Study of Clinical and Ultrasound Parameters for Defining a Difficult Airway in Patients with Obesity. Obes Surg. 2021 Sep;31(9):4118-4124. doi: 10.1007/s11695-021-05528-1. Epub 2021 Jul 5. — View Citation

Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017 Apr 1;118(4):601-609. doi: 10.1093/bja/aex051. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	midsagittal tongue cross- sectional area	To evaluate the capability of midsagittal tongue cross- sectional area measured by ultrasound to predict difficult laryngoscopy and difficult intubation.	All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.
Primary	tongue width	To evaluate the capability of tongue widht measured by ultrasound to predict difficult laryngoscopy and difficult intubation.	All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.