- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05961254
Role of Airwayultrasound in Predicting Difficult Endotracheal Intubation in Patients Undergoing General Anesthesia
Unpredictable difficult endotracheal intubation remains a challenge especially if difficult ventilation occurs. Difficult intubation is associated with many severe fatal complications including air way trauma, laryngospasm, hypoxemia, arrhythmias and potential cardiac arrest. Therefore, preoperative evaluation and prediction of potential difficult airway is very important.
Several screening tests are used in clinical practice to identify patients at the risk of difficult airway. Despite their accuracy and benefit, a small number of patients classified to an easy airway may still present an unexpected difficulty. Predicting a difficult airway is not at all an easy task for all patients .
Incidence of difficult airway and difficult intubation varies from 5% to 22% with important implications for clinical practice and patients' outcomes .
There are multiple scores used for airway assesment ,the commonest one is LEMON score. LEMON is an airway assessment score that measures factors associated with difficult intubation such as obesity, head and neck movement, jaw movement , receding mandible, long upper incisors, Mallampatti scores, maxillary incisor characteristics, decreased mouth opening ,shorten thyromental distance and short neck .
Diagnostic criteria for LEMON scoring system :
L- Look. E- Evaluation using the 3-3-2 rule. M- Mallampati. O- Obstruction. N- Neck mobility. Ultrasound (US) imaging technique is simple, portable, noninvasive tool helpful for airway assessment and management. In the last few years, there have been some reports that described various roles of US imaging in airway management. It helps in rapid assessment of the airway anatomy, not only in operation theatre but also in the intensive care unit and emergency department.
Various clinical applications of US imaging of the upper airway include identification of endotracheal tube (ETT) placement, guidance of percutaneous tracheostomy and cricothyroidotomy, detection of subglottic stenosis, prediction of difficult intubation and post-extubation stridor, prediction of paediatric ETT and double-lumen tube (DLT) size.
Recently there are researches about airway assesment by ultrasound. Several airway assesment indicies are used to help in prediction of difficult endotracheal intubation. The most commonly used indices are distance from skin to epiglottis, distance from skin to vocal cord level, and distance from skin to hyoid bone.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Meril N Saleeb, resident
- Phone Number: 01287178283
- Email: mirelnasry@med.sohag.edu.eg
Study Contact Backup
- Name: Abdelrahman H Abdelrahman, professor
Study Locations
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Sohag, Egypt
- Sohag University Hospital
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Contact:
- Magdy M Amin, Professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients from 18- 50 yrs old
- Patients who require endotracheal intubation for surgery under general anesthesia.
Exclusion Criteria:
- Patients with history of previous difficult intubation.
- Neck deformity such as swelling , scar ,etc.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ultasound airway assesment index ..distance from skin to epiglottis
Time Frame: 6 months
|
to measure distance from skin to epiglottis
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6 months
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ultasound airway assesment index ..distance from skin to hyoid bone
Time Frame: 6 months
|
to measure distance from skin to hyoid bone
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6 months
|
ultasound airway assesment index ..distance from skin to vocal cord
Time Frame: 6 months
|
to measure distance from skin to vocal cord
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
airway ultrasound and LEMON score
Time Frame: 6 months
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compare between LEMON score and airway ultrasound in predicting difficult airway.
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6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
- Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
- Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, Herkner H. Bedside tests for predicting difficult airways: an abridged Cochrane diagnostic test accuracy systematic review. Anaesthesia. 2019 Jul;74(7):915-928. doi: 10.1111/anae.14608. Epub 2019 Mar 6.
- Detsky ME, Jivraj N, Adhikari NK, Friedrich JO, Pinto R, Simel DL, Wijeysundera DN, Scales DC. Will This Patient Be Difficult to Intubate?: The Rational Clinical Examination Systematic Review. JAMA. 2019 Feb 5;321(5):493-503. doi: 10.1001/jama.2018.21413. Erratum In: JAMA. 2020 Mar 24;323(12):1194.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-23-07-19MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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