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OpenTrials
Completed

NCT Number: NCT05519358

Midsagittal Tongue Measurement to Predict Difficult Airways

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University Faculty of medicine

Samsun, 55040, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. midsagittal tongue cross- sectional area

    Time frame: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.

    To evaluate the capability of midsagittal tongue cross- sectional area measured by ultrasound to predict difficult laryngoscopy and difficult intubation.

  2. tongue width

    Time frame: All of the enrolled patients received ultrasonic measurement in the operation room before anesthesia on the day of surgery.

    To evaluate the capability of tongue widht measured by ultrasound to predict difficult laryngoscopy and difficult intubation.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 29, 2022
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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