Clinical trial NCT04140357: Role of Ultrasonography in Airway Management
Official title: Is There a Role for Ultrasonography in the Airway Management of Patients With Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obese Patients
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obesity body mass index \>30 undergoing surgery and requiring tracheal intubation

Brief summary: Ultrasound is one of the most useful devices in daily anesthesia practice. Latest purpose of ultrasound usage is prediction of difficult intubation. In this study, we aimed to predict difficult laryngoscopy and intubation by using ultrasound measurement of neck soft tissue thickness in obese patient preoperatively.

Detailed description: In this prospective and randomized controlled study, mallampati scores, interincisor gap, thyromental distance, neck circumference measurement and upper lip bite test scores will be recorded in sixty obese patients.

Additionally, neck tissue thickness will be recorded at 4 different levels (hyoid bone-skin distance, epiglot-skin distance , thyroid istmus-skin distance, vocal cord-skin distance) after the sniffing position by ultrasound with the linear probe. All measurements will be repeated three times and an average values will be recorded.

After all this measurements, endotracheal intubation will be performed by an experienced anesthetist who is uninformed about study. During intubation the Cormack Lehane (C/L, grade 1: full view of the vocal cords; grade 2a: partial view of the glottis; 2b: posterior part of the vocal cord and arytenoids visible; grade 3: only epiglottis visible; and grade 4: neither epiglottis nor glottis visible) and the Intubation Difficulty Scale (IDS) score (the numbers of attempts, operators, and alternative techniques used, the C/L grade of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords. Every insertion of the laryngoscope and advancement of the tracheal tube towards the glottis counted as an attempt. A score of \>5 indicates moderate-to-major difficulty) will be recorded.

Eligibility criteria: Inclusion Criteria:

* BMI\>30
* 18-65 YEARS
* ASA 1-2-3
* Obese patients

Exclusion Criteria:

* Pregnancy
* Upper airway pathology
* Cervical spine pathology
* Laryngeal pathology

Primary outcomes:
measure: Hyoid bone-skin distance -effect of ultrasound on prediction of difficult laryngoscopy
timeFrame: 30 minutes before induction
measure: Epiglottis-skin distance
timeFrame: 30 minutes before induction
measure: Thyroid isthmus-skin distance
timeFrame: 30 minutes before induction
measure: Vocal cord-skin distance
timeFrame: 30 minutes before induction
Secondary outcomes:
measure: Intubation difficulty scale score
timeFrame: 1 minutes after intubation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başak Gülel
state: Province
Study officials:
affiliation: Sbü Dışkapı Yıldırım Beyazıt Eğitim Ve Araştırma Hastanesi
name: Basak Gulel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Qasmi A, Al-Alawi W, Malik AM, Manzoor Khan R, Kaul N. Comparison of Tracheal Intubation Using the Storz's C-Mac D-blade(TM) Video-Laryngoscope Aided by Truflex(TM) Articulating Stylet and the Portex(TM) Intubating Stylet. Anesth Pain Med. 2015 Dec 5;5(6):e32299. doi: 10.5812/aapm.32299. eCollection 2015 Dec.
citation: Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
citation: Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.
citation: Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005 Aug;103(2):429-37. doi: 10.1097/00000542-200508000-00027.