Clinical trial NCT06611917: Diagnostic Values of Physical Examination and Ultrasonographic Measurements in Predicting Difficult Airways
Official title: Comparative Diagnostic Values of Physical Examination Tests and Ultrasonographic Measurements in Predicting Difficult Airways
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Keywords: Airway Management
Endotracheal Intubation
Ultrasonography
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-60 years undergoing surgery under general anesthesia with an ASA classification of 1-3.

Brief summary: This study evaluates the effectiveness of ultrasonographic measurements compared to traditional physical examination tests in predicting difficult airways. With no definitive gold standard for anticipating airway challenges, this research explores the diagnostic capabilities of newer, non-invasive techniques like ultrasonography-which is gaining popularity due to its ease of use and widespread availability-in the field of anesthesia. The study focuses on defining highly sensitive and easy-to-use ultrasonographic markers that could aid anesthesiologists, intensive care specialists, and emergency physicians in effective airway management.

Detailed description: Anesthesiologists, intensive care specialists, and emergency physicians frequently encounter the challenge of managing difficult airways, a critical competency as failure to secure the airway can lead to severe consequences, including brain damage or death. Intubation, a complex procedure involving several anatomical maneuvers, has traditionally relied on physical examination indicators such as dental and facial anatomy, Mallampati score, and neck mobility to predict potential difficulties. However, these methods, while useful, often lack the accuracy needed for reliable prediction, leading to a significant percentage of unexpected difficult intubations.

Recent advances in medical imaging propose the use of radiological and ultrasonographic assessments to enhance predictive accuracy. Ultrasonography, in particular, offers a non-invasive, easily accessible method for examining airway structures, which could potentially transform standard practices in airway management. The American Society of Anesthesiologists recognizes the promising role of ultrasound in airway assessment, yet acknowledges the need for more standardized approaches to its implementation.

This research aims to compare the predictive value of physical examination findings with that of ultrasonographic measurements such as the distance from skin to hyoid bone, skin to epiglottis, and tongue volume. By establishing more reliable and sensitive ultrasonographic markers, this study seeks to provide clinicians with better tools for assessing the risk of difficult airways, ultimately contributing to safer anesthesia practices and reducing the incidence of intubation-related complications.

Eligibility criteria: Inclusion Criteria:

* Patients classified as American Society of Anesthesiologists (ASA) class I-II-III.
* Individuals aged between 18 and 60 years.
* Patients scheduled for elective surgery require endotracheal intubation under general anesthesia

Exclusion Criteria:

* Patients with pathologies in the airway or head and neck area (masses, cancer, congenital anomalies, acquired anatomical disorders).
* Individuals with active infections.
* Those with cervical vertebral damage.
* Patients with a history of head and neck trauma.
* Individuals who have undergone previous head and neck surgery.
* Patients with a history of head and neck radiotherapy.
* Pregnant individuals.
* Obese patients (body mass index \> 30).
* Non-cooperative patients.
* Patients are requiring surgery under emergency conditions.

Primary outcomes:
measure: Effectiveness of Difficult Airway Prediction
timeFrame: up to one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Canakkale Onsekiz Mart University
state: Merkez
Study officials:
References: