Clinical trial NCT04205331: Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients
Official title: Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients: A Cross Sectional Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difficult Airway Intubation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-12-19
Enrollment: 78
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted at Zagazig University Hospitals.The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia.

Brief summary: Since the introduction of real-time ultrasound (US) capabilities, ultrasound technology has been adopted and incorporated into daily practice by many medical and surgical specialties. Using US to help assess the difficult airway constitutes just yet another valuable application of this versatile technology . Since many anesthesia providers had already acquired proficiency in US techniques in US guided vascular access and regional nerve blocks, using US to evaluate the airway could be learned and mastered without too much difficulty. Ultrasound of the upper airway may prove to become a useful adjunct to conventional clinical assessment tools, as it has been successful in visualizing the relevant anatomy and critical structures of the airway..

Detailed description: The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia..

Eligibility criteria: Inclusion Criteria:

* Age of the patient : (21-60) years old.
* Sex : male \& female.
* Physical Status : The American Society of Anesthesiologists (ASA) II-III patients.
* Body mass index : 30 to more than 30 kg / m² .
* Operations: Laparoscopic surgeries,bariatric surgeries and any operation that requires general anesthesia with endotracheal tube placement .

Exclusion Criteria:

Patient refusal.

* Deformity of the airway anatomy \[by masses or tumors\].
* Patients with thyroid swellings 'Goitre'.
* Pathology of the airway \[edema,burn and arthritis\].

Primary outcomes:
measure: The ratio of the depth of the pre-epiglottic space (Pre-E) to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC).
timeFrame: through study completion, an average of 1 year
measure: The anterior neck soft tissue thickness at the level of the vocal cords (ANS-VC)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The anterior neck soft tissue thickness at the level of the hyoid bone (ANS-Hyoid)
timeFrame: through study completion, an average of 1 year
measure: The hyomental distance of the patient in neutral position of the neck and in fully extended neck calculating the ratio between both of them
timeFrame: through study completion, an average of 1 year
measure: Tongue volume will be derived from multiplication of the midsagittal cross-sectional area of the tongue by its width obtained from transverse sonograms
timeFrame: through study completion, an average of 1 year
measure: Modified Mallampati classification
timeFrame: through study completion, an average of 1 year
measure: Interincisor gap
timeFrame: through study completion, an average of 1 year
measure: Thyromental distance
timeFrame: through study completion, an average of 1 year
measure: Sternomental distance
timeFrame: through study completion, an average of 1 year
measure: Neck Extension and Flexion
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: Zagazig University
name: Ahmed El-Tawansy, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: