- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495596
Predictors of Difficult Videolaryngoscopy
April 5, 2022 updated by: Sevilay Kivrakoglu, Hacettepe University
Determination of Factors Leading to Failure of Videolaryngoscopy
The primary goal of this study was to identify parameters affecting the failure of videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and the most frequently used patient groups.
Study Overview
Detailed Description
Videolaryngoscopy is widely used in the management of patients with presumed difficult airway.
It offers an improved laryngeal view compared with direct laryngoscopy and increases the likelihood of successful intubation in patients for whom direct laryngoscopy is anticipated to be difficult.
It is among the most frequently preferred difficult airway devices due to its ease of use, portability and direct laryngoscopy resemblance.
The use of videolaryngoscopy has been shown to improve intubation success in many cases associated with difficult intubation, such as morbid obesity, pregnancy, limitation of cervical motility, and poor mouth opening.
Study Type
Observational
Enrollment (Actual)
1159
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06100
- Hacettepe University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 95 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who will undergo surgery under general anesthesia will be followed in Hacettepe University Hospital's operating room.
All patients aged 0-95 years who used videolaryngoscopy will be included in the study.
Description
Inclusion Criteria:
- All patients who used videolaryngoscopy for intubation
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Videolaryngoscopy patients
The patients who were attempted to be intubated with videolaryngoscopy
|
Videolaryngoscopy device type
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation success
Time Frame: 15 minutes
|
The success of intubation attempt with videolaryngoscopy (yes/no)
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The reason of videolaryngoscopy
Time Frame: 15 minutes
|
Why videolaryngoscopy is preferred instead of standard direct laryngoscopy
|
15 minutes
|
|
The type of videolaryngoscopy blade
Time Frame: 15 minutes
|
acute angled/macintosh/miller blade
|
15 minutes
|
|
The rescue technique
Time Frame: 30 minutes
|
The rescue technique used for patients who could not be intubated with videolaryngoscopy
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30 minutes
|
|
Factors affecting success of videolaryngoscopy
Time Frame: 30 minutes
|
Mallampati score, thyromental distance, neck movements, upper lip bite test, mouth opening
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30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aysun Ankay Yilbas, MD, Turkish Society of Anesthesiology and Reanimation
- Principal Investigator: Sevilay Kivrakoglu, MD, Turkish Society of Anesthesiology and Reanimation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
- Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.
- Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.
- el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017.
- Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
- Toshniwal G, McKelvey GM, Wang H. STOP-Bang and prediction of difficult airway in obese patients. J Clin Anesth. 2014 Aug;26(5):360-7. doi: 10.1016/j.jclinane.2014.01.010. Epub 2014 Jul 28.
- Nakao K, Komasawa N, Kusaka Y, Minami T. Rapid-Sequence Intubation in the Left-Lateral Tilt Position in a Pregnant Woman with Premature Placental Abruption Utilizing a Videolaryngoscope. AJP Rep. 2015 Apr;5(1):e30-2. doi: 10.1055/s-0034-1544109. Epub 2015 Feb 25.
- Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.
- Wilson ME, Spiegelhalter D, Robertson JA, Lesser P. Predicting difficult intubation. Br J Anaesth. 1988 Aug;61(2):211-6. doi: 10.1093/bja/61.2.211.
- Nath G, Sekar M. Predicting difficult intubation--a comprehensive scoring system. Anaesth Intensive Care. 1997 Oct;25(5):482-6. doi: 10.1177/0310057X9702500505.
- Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021. Erratum In: Anesthesiology 1993 Jan;78(1):224.
- Williamson JA, Webb RK, Szekely S, Gillies ER, Dreosti AV. The Australian Incident Monitoring Study. Difficult intubation: an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):602-7. doi: 10.1177/0310057X9302100518.
- Nichol HC, Zuck D. Difficult laryngoscopy--the "anterior" larynx and the atlanto-occipital gap. Br J Anaesth. 1983 Feb;55(2):141-4. doi: 10.1093/bja/55.2.141.
- Oates JD, Macleod AD, Oates PD, Pearsall FJ, Howie JC, Murray GD. Comparison of two methods for predicting difficult intubation. Br J Anaesth. 1991 Mar;66(3):305-9. doi: 10.1093/bja/66.3.305.
- Charters P, Perera S, Horton WA. Visibility of pharyngeal structures as a predictor of difficult intubation. Anaesthesia. 1987 Oct;42(10):1115. doi: 10.1111/j.1365-2044.1987.tb05182.x. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 17, 2018
Primary Completion (ACTUAL)
March 1, 2020
Study Completion (ACTUAL)
March 1, 2020
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 5, 2018
First Posted (ACTUAL)
April 12, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 5, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Videolaryngoscopy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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