Clinical trial NCT05961254: Role of Airwayultrasound in Predicting Difficult Endotracheal Intubation in Patients Undergoing General Anesthesia
Official title: Role of Airwayultrasound in Predicting Difficult Endotracheal Intubation in Patients Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Predict Diificult Endotracheal Intubation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients from 18- 50 yrs old Patients who require endotracheal intubation for surgery under general anesthesia.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: ultasound airway assesment index ..distance from skin to epiglottis
timeFrame: 6 months
measure: ultasound airway assesment index ..distance from skin to hyoid bone
timeFrame: 6 months
measure: ultasound airway assesment index ..distance from skin to vocal cord
timeFrame: 6 months
Secondary outcomes:
measure: airway ultrasound and LEMON score
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.