Evaluation of Difficult Airway With Ultrasonography

NCT ID: NCT04289597

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2022-03-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Difficult Intubation Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese patients

Obese patients with BMI\>30

Distance between hyoid bone-skin (DSHB)

Intervention Type DIAGNOSTIC_TEST

Distance between hyoid bone-skin

Vocal cord anterior commissura-skin distance (DSAC)

Intervention Type DIAGNOSTIC_TEST

Vocal cord anterior commissura-skin distance

minimum distance of the trachea to the skin at the level of suprasternal notch

Intervention Type DIAGNOSTIC_TEST

Distance of the trachea to the skin at the level of suprasternal notch

Thyroid isthmus-skin distance (DSI)

Intervention Type DIAGNOSTIC_TEST

Thyroid isthmus-skin distance

Skin-epiglottic distance (DSE)

Intervention Type DIAGNOSTIC_TEST

Skin-epiglottic distance

Interventions

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Distance between hyoid bone-skin (DSHB)

Distance between hyoid bone-skin

Intervention Type DIAGNOSTIC_TEST

Vocal cord anterior commissura-skin distance (DSAC)

Vocal cord anterior commissura-skin distance

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Thyroid isthmus-skin distance (DSI)

Thyroid isthmus-skin distance

Intervention Type DIAGNOSTIC_TEST

Skin-epiglottic distance (DSE)

Skin-epiglottic distance

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DSHB DSAC DST DSI DSE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Meryem Onay

Specialist Doctor-Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meryem Onay, MD

Role: PRINCIPAL_INVESTIGATOR

Teaching Assistant

Locations

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Eskisehir Osmangazi Univercty

Odunpazari, Eskişehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25403231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14616599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30894124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23836064 (View on PubMed)

Lundstrom LH, Moller 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.

Reference Type BACKGROUND
PMID: 19194154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22401881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31742568 (View on PubMed)

Other Identifiers

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ESOGU

Identifier Type: -

Identifier Source: org_study_id

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