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

NCT04205331 | Unknown DMC

• 1 other identifier: 5162-23-1-2019
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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..

Conditions

Difficult Airway Intubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• The anterior neck soft tissue thickness at the level of the hyoid bone (ANS-Hyoid)

  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

  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

  through study completion, an average of 1 year

• Modified Mallampati classification

  through study completion, an average of 1 year

• Interincisor gap

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients DEVICE

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

obese patients

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Egypt

RECRUITING

Study Officials

• Ahmed El-Tawansy, M.Sc.

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

El-Tawansy

CONTACT

0201005125451; medicinemia@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 19, 2019
• Study Start: December 14, 2019
• Primary Completion: September 20, 2020
• Study Completion: October 20, 2020
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: anesthesiologists who are interested in airway management

Locations

EG (1)