Clinical trial NCT05519358: Midsagittal Tongue Measurement to Predict Difficult Airways
Official title: Efficacy of Midsagittal Tongue Cross-section Area Measured by Ultrasound in Predicting Difficult Airway in Obesity Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Airway
Ultrasonography
Keywords: Airway management
Ultrasonography
Tongue widht
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are18 to 90 years old and of either sex who required general anesthesia with tracheal intubation for bariatric surgery .

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: midsagittal tongue cross- sectional area
timeFrame: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.
measure: tongue width
timeFrame: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University Faculty of medicine
Study officials:
affiliation: Samsun Univercity
name: Suna KARAGÖRMÜŞ
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.