Clinical trial NCT04273074: Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx
Official title: Point of Care Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx in Obese Patients Undergoing Bariatric Surgery: a Comparison With the Conventional Cormack-Lehane Classification During Direct Laryngoscopy: an Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Assessment
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: failed and Difficult tracheal intubation after direct laryngoscopy is a dreaded complication of general anesthesia as it is associated with serious morbidity and mortality. There are several conventional clinical airway assessment parameters such as the modified Mallampati classification,thyromental and hyomental distance, interincisor distance, neck movementsand neck circumference, which are usually used to predict a difficult airwayand are components of multivariate risk indices. Despite the use of these parameters, the diagnostic accuracy of a preanesthetic airway assessment in predicting difficult intubation is very low. Ultrasound has been evolving as a useful device for airway assessment,and sublingual ultrasound has been used for this purpose.

Detailed description: By an anesthesiologist who is experienced in airway ultrasound, patients will preoperative sonographic assessment . the patient will lie in the ramped up position , with head in the neutral position.The linear probe of the ultrasound machine will be used. Under the patient's chin, The probe of ultrasond will be placed , at different levels, to get the of the submandibular area in transverse view and the upper part of the neck. The transverse view will be used for measuring the the skin to hyoid, tongue volume,and the skin to epiglottis distance. The mid-sagittal view will be used for measuring the distance between epiglottis ,pre-epiglottic space , vocal cords, and the neck fat volume .

Eligibility criteria: Inclusion Criteria:

1. Adult patients above 18 years of age.
2. Both genders
3. Patients scheduled for elective surgery under general anesthesia
4. Obese patients with BMI \> 30 kg/m2

Exclusion Criteria:

1. Patients with psychological disorders or those lacking co-operation.
2. Patients with maxillofacial anomalies, restricted neck movements and limited mouth opening.
3. American Society of Anesthesiologists (ASA) physical status class IV
4. Emergency operations

Primary outcomes:
measure: Epiglottis-to-vocal-cord distance
timeFrame: during examination up to 1 hours
Secondary outcomes:
measure: Tongue width
timeFrame: UP TO 1 HOURE
measure: Modified Mallampati class
timeFrame: UP TO 1 HOURE
measure: the time needed to perform the ultrasound examination.
timeFrame: UP TO 1 HOURE
measure: Pre-epiglottic space
timeFrame: UP TO 1 HOURE
measure: Pre-epiglottic space
timeFrame: up to 1 hour
measure: Skin to hyoid distance
timeFrame: up to 1 hour
measure: Skin to epiglottis distance
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Professor of Anaesthesia, surgical ICU &Pain management
name: Nadia Helmy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: lecturer of Anesthesiology
name: Yasmine salah
role: PRINCIPAL_INVESTIGATOR
References: