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

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

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..

Study Overview

• Status: Unknown
• Conditions: Difficult Airway Intubation
• Intervention / Treatment: Device: Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients

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..

• Study Type: Observational
• Enrollment (Anticipated): 78

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Recruiting
    • Zagazig University
    • Contact: El-Tawansy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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].

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obese patients; compare between ultrasonography and conventional clinical methods of airway assessment prior to induction of anesthesia correlating it to the Cormack-Lehane scoring system after induction of anesthesia in obese patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Thyromental distance	If < 6cm ,this predicts difficult laryngoscopy	through study completion, an average of 1 year
Sternomental distance	If < 12.5 cm ,this predicts difficult laryngoscopy	through study completion, an average of 1 year
Neck Extension and Flexion	inability to extend or flex the neck suspects difficult laryngoscopy	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Ahmed El-Tawansy, M.Sc., Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2019
• Primary Completion (Anticipated): September 20, 2020
• Study Completion (Anticipated): October 20, 2020

Study Registration Dates

• First Submitted: December 14, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 5162-23-1-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol and Results will be shared with other researchers.
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: anesthesiologists who are interested in airway management
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No