- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140357
Role of Ultrasonography in Airway Management
Is There a Role for Ultrasonography in the Airway Management of Patients With Obesity
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Basak Gulel
- Phone Number: 05061436261
- Email: dr.basakdemir@gmail.com
Study Contact Backup
- Name: Emine Arik
- Phone Number: 05333471530
- Email: emineincearik@yahoo.com
Study Locations
-
-
Province
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Ankara, Province, Turkey, 06080
- Başak Gülel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- BMI>30
- 18-65 YEARS
- ASA 1-2-3
- Obese patients
Exclusion Criteria:
- Pregnancy
- Upper airway pathology
- Cervical spine pathology
- Laryngeal pathology
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hyoid bone-skin distance -effect of ultrasound on prediction of difficult laryngoscopy
Time Frame: 30 minutes before induction
|
The hyoid bone-skin distance will be measured by using ultrasound in centimeters
|
30 minutes before induction
|
Epiglottis-skin distance
Time Frame: 30 minutes before induction
|
The epiglottis-skin distance will be measured by using ultrasound in centimeters
|
30 minutes before induction
|
Thyroid isthmus-skin distance
Time Frame: 30 minutes before induction
|
The thyroid isthmus-skin distance will be measured by using ultrasound in centimeters
|
30 minutes before induction
|
Vocal cord-skin distance
Time Frame: 30 minutes before induction
|
The vocal cord-skin distance will be measured by using ultrasound in centimeters
|
30 minutes before induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation difficulty scale score
Time Frame: 1 minutes after intubation
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Basak Gulel, Sbü Dışkapı Yıldırım Beyazıt Eğitim Ve Araştırma Hastanesi
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BasakUltrasonografi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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