Evaluation of Difficult Airway With Ultrasonography

Obesity Clinical Trial

Official title:

Evaluation of Difficult Airway in Obese Patients With Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289597
• Other study ID #: ESOGU
• Status: Completed
• Start date: August 20, 2020
• Est. completion date: March 11, 2022

Study information

• Verified date: March 2022
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

As a result of anatomical and physiological changes in obese patients, airway management can be challenging. Ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. In this study we planned to evaluate the measurement of neck anterior soft tissues by ultrasound in obese patients before anesthesia induction to anticipate difficult mask ventilation, difficult laryngoscopy, and intubation.

Description:

Patients with BMI> 30, schedule elective surgery under general anesthesia, and give consent will be included in the study. In the preoperative evaluation, demographic data of the patients, airway physical examination results (mouth opening, Mallampati score, thyromental distance, neck circumference (from thyroid cartilage level), abnormal upper tooth presence, neck movement restriction], presence of sleep apnea and STOP-BANG score will be recorded. In the patients taken on the operation table with supine position, ultrasound-guided soft tissue distances will be measured using ultrasound 6-13 Hz linear probe. The distance between the hyoid bone-skin (DSHB), the vocal cord anterior commissura-skin distance (DSAC), the minimum distance of the trachea to the skin at the level of the suprasternal notch (DST), the distance between the thyroid isthmus and the skin (DSI), and the distance between the epiglottis and the skin (DSE) will be measured and recorded. After standard monitoring and anesthesia induction, difficult mask ventilation will be evaluated with Han Scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation. Difficult laryngoscopy will be evaluated with Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy. Difficult intubation will also be evaluated with the number and duration of intubation attempts with the Macintosh blade. Tracheal intubation will be performed by an anesthesiologist who has at least two years of experience and unaware of ultrasound measurements. The duration of intubation (the time from the first handling of the laryngoscope until the capnography trace appeared) and the number of trials will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients planned to undergo general anesthesia for elective surgery

• American Anesthesiology Association physical classification (ASA) status I-III

• Body mass index (BMI) above 30

Exclusion Criteria:

• Patients with neck mass

• History of previous neck and thyroid surgery, trauma, arthritis, loss of teeth

• History of difficult intubation

• Bearded patients

• Pregnant women

Related Conditions & MeSH terms

• Difficult Intubation
• Obesity

Intervention

Diagnostic Test:
• Distance between hyoid bone-skin (DSHB)
Distance between hyoid bone-skin
• Vocal cord anterior commissura-skin distance (DSAC)
Vocal cord anterior commissura-skin distance
• minimum distance of the trachea to the skin at the level of suprasternal notch
Distance of the trachea to the skin at the level of suprasternal notch
• Thyroid isthmus-skin distance (DSI)
Thyroid isthmus-skin distance
• Skin-epiglottic distance (DSE)
Skin-epiglottic distance

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi Univercty	Odunpazari	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989. — View Citation

Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8. — 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

Liang H, Hou Y, Wei H, Feng Y. Supraglottic jet oxygenation and ventilation assisted fiberoptic intubation in a paralyzed patient with morbid obesity and obstructive sleep apnea: a case report. BMC Anesthesiol. 2019 Mar 20;19(1):40. doi: 10.1186/s12871-019-0709-7. — View Citation

Lundstrøm LH, Møller AM, Rosenstock C, Astrup G, Wetterslev J. High body mass index is a weak predictor for difficult and failed tracheal intubation: a cohort study of 91,332 consecutive patients scheduled for direct laryngoscopy registered in the Danish Anesthesia Database. Anesthesiology. 2009 Feb;110(2):266-74. doi: 10.1097/ALN.0b013e318194cac8. — View Citation

Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9. — 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	Difficult Mask Ventilation	Difficult mask ventilation will be evaluated with Han scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation.	''1 minute'' (During anesthesia induction)
Secondary	Difficult laryngoscopy	Difficult laryngoscopy will be evaluated Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy.	''1 minute''
Secondary	Difficult intubation	Total number of intubation attempts	''1 minute''
Secondary	The duration of endotracheal intubation time	The time from the first handling of the laryngoscope until the capnography trace appeared	1 minute