Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients

Difficult Airway Intubation Clinical Trial

Official title:

Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients: A Cross Sectional Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205331
• Other study ID #: 5162-23-1-2019
• Status: Recruiting
• Start date: December 14, 2019
• Est. completion date: October 20, 2020

Study information

• Verified date: December 2019
• Source: Zagazig University
• Contact: El-Tawansy
• Phone: 0201005125451
• Email: medicinemia[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: October 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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].

Related Conditions & MeSH terms

• Difficult Airway Intubation

Intervention

Device:
• Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients
Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	If It is [0-1] ,this suspects Cormack-Lehane Grade 1.If it is [1-2],this suspects Cormack-Lehane Grade 2.If it is [2-3],this suspects Cormack-Lehane Grade 3	through study completion, an average of 1 year
Primary	The anterior neck soft tissue thickness at the level of the vocal cords (ANS-VC)	ANS-VC >0.23 cm had a sensitivity of 85.7% in predicting a Cormack-Lehan Grade 3 or 4	through study completion, an average of 1 year
Secondary	The anterior neck soft tissue thickness at the level of the hyoid bone (ANS-Hyoid)	If it is 1.69 cm [1.19 cm to 2.19 cm],this suspects difficult laryngoscopy.If it is 1.37cm [1.27 cm to 1.46 cm], this suspects easy laryngoscopy	through study completion, an average of 1 year
Secondary	The hyomental distance of the patient in neutral position of the neck and in fully extended neck calculating the ratio between both of them	If The mean hyomental distance ratios is (1.02 ± 0.01) ,this suspects difficult intubation.If it is (1.14 ± 0.02) ,this suspects easy intubation	through study completion, an average of 1 year
Secondary	Tongue volume will be derived from multiplication of the midsagittal cross-sectional area of the tongue by its width obtained from transverse sonograms	Large tongue volume suspects difficult laryngoscopy	through study completion, an average of 1 year
Secondary	Modified Mallampati classification	Class I is visualization of the hard palate, soft palate, fauces, uvula, and pillars.; Class II is visualization of the hard palate, soft palate, fauces, and base of uvula.; Class III is visualization of the hard palate and soft palate. Class IV is visualization of only the hard palate	through study completion, an average of 1 year
Secondary	Interincisor gap	If it is less than 5 cm (approximately three finger breadths) with limited forward protrusion of the mandible ,this is associated with increased risk of difficult laryngoscopy	through study completion, an average of 1 year
Secondary	Thyromental distance	If < 6cm ,this predicts difficult laryngoscopy	through study completion, an average of 1 year
Secondary	Sternomental distance	If < 12.5 cm ,this predicts difficult laryngoscopy	through study completion, an average of 1 year
Secondary	Neck Extension and Flexion	inability to extend or flex the neck suspects difficult laryngoscopy	through study completion, an average of 1 year