Role of Ultrasonography in Airway Management

Obese Patients Clinical Trial

Official title:

Is There a Role for Ultrasonography in the Airway Management of Patients With Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04140357
• Other study ID #: BasakUltrasonografi
• Status: Not yet recruiting
• Start date: November 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: October 2019
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Basak Gulel
• Phone: 05061436261
• Email: dr.basakdemir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI>30

• 18-65 YEARS

• ASA 1-2-3

• Obese patients

Exclusion Criteria:

• Pregnancy

• Upper airway pathology

• Cervical spine pathology

• Laryngeal pathology

Related Conditions & MeSH terms

• Obese Patients

Locations

Country	Name	City	State
Turkey	Basak Gülel	Ankara	Province

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Ezri T, Gewürtz 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyoid bone-skin distance -effect of ultrasound on prediction of difficult laryngoscopy	The hyoid bone-skin distance will be measured by using ultrasound in centimeters	30 minutes before induction
Primary	Epiglottis-skin distance	The epiglottis-skin distance will be measured by using ultrasound in centimeters	30 minutes before induction
Primary	Thyroid isthmus-skin distance	The thyroid isthmus-skin distance will be measured by using ultrasound in centimeters	30 minutes before induction
Primary	Vocal cord-skin distance	The vocal cord-skin distance will be measured by using ultrasound in centimeters	30 minutes before induction
Secondary	Intubation difficulty scale score	Each number of numbers attempt, operator and alternative techniques used, the Cormack Lehane score of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords count 1 point. A score of >5 indicates moderate-to-major difficulty	1 minutes after intubation