- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07355608
Videolaryngoscopic Difficult ıntubation and Glottic View Score: A Multicentre Prospective Study (VIDIGLOV)
Prediction of Difficult Videolaryngoscopic Intubation and Development of a Dedicated Glottic View Score: A Multicentre Prospective Study
Background:
Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation.
Objectives:
This study aims to:
- Develop a predictive model for difficult VL intubation in surgical patients with both normal and anticipated difficult airways.
- Create a glottic view scoring system specifically tailored to videolaryngoscopy.
- Compare the predictive accuracy of the new scoring system with existing laryngeal view grades in forecasting difficult VL intubation.
Study Overview
Status
Conditions
Detailed Description
Background:
Videolaryngoscopy has improved glottic visualization and facilitated tracheal intubation. However, difficulties-including failed intubation-still occur. At present, no prospectively derived classification system exists to assess the difficulty of videolaryngoscopic (VL) intubation across both normal and anticipated difficult airways. Additionally, current glottic view grading systems, designed for direct laryngoscopy, may not adequately capture the specific challenges of VL intubation.
Objectives:
This study aims to:
- Develop a predictive model for difficult VL intubation in surgical patients with both normal and anticipated difficult airways.
- Create a glottic view scoring system specifically tailored to videolaryngoscopy.
- Compare the predictive accuracy of the new scoring system with existing laryngeal view grades in forecasting difficult VL intubation.
Methods:
A prospective cohort of 4,977 patients will be enrolled. Patient and intubation related variables-including VL findings, airway features, clinical parameters, device, and procedural details-will be analyzed. Binary logistic regression will be employed to build the initial predictive model. In parallel, machine learning techniques (Random Forest, Support Vector Machine, XGBoost, LightGBM, etc.) will be applied to evaluate predictive performance. Comparative analysis will be conducted between the machine learning models and the logistic regression baseline.
Expected Impact:
The development of a robust predictive tool and an associated VL-specific glottic view score could enhance clinical decision making, particularly in identifying patients at risk of difficult or failed VL intubation. This may support early consideration of awake tracheal intubation, and use of standardized terminology and reduce complications associated with difficult airway management
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dilek Yazıcıoğlu Ünal, Professor
- Phone Number: +90 5336957855
- Email: dilekunalmd@gmail.com
Study Contact Backup
- Name: Emel Gündüz, assoc.
- Phone Number: +905444341719
- Email: dregunduz@hotmail.com,
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06170
- Etlik City Hospital
-
Contact:
- Dilek Unal yazıcıoğlu, Professor
- Phone Number: +905336957855
- Email: dilekunalmd@gmail.com
-
Contact:
- Emel Gündüz
- Phone Number: +905444341719
- Email: drgunduz@hotmai.com
-
Antalya, Turkey (Türkiye)
- Akdeniz University Medical Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults
- Both with normal or predicted difficult airways
- Undergoing orotracheal intubation with a videolarygoscope
Exclusion Criteria:
- Rapid sequence intubation
- Double lumen tube intubation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glottic view description
Time Frame: 2 minutes after anesthesia induction
|
Vocal cords are fully visible Vocal cords are partially separately Vocal cords are not visible Cords are adducted Epiglottis is visible Epiglottis is large Epiglottis is small Epiglottis is edematous Epiglottis mass is present Arytenoids are visible Arytenoid luxation or subluxation Arytenoid edema Valecula problem (edema, Coffee grounds, etc., unable to insert a blade) Aryepiglottic plica pathology (edema, Coffee grounds scar) Laryngeal structures should be formed Glottic stenosis Laryngospasm
|
2 minutes after anesthesia induction
|
|
Failed first intubation attempt
Time Frame: 2 minutes after anesthesia induction
|
Failed to intubate at firtst attempt
|
2 minutes after anesthesia induction
|
|
Difficult intubation
Time Frame: 2 minutes after anesthesia induction
|
Failed to intubate at 1-2 attempts and/or intubation duration longer than 120 second
|
2 minutes after anesthesia induction
|
|
Failed intubation
Time Frame: 2 minutes after anesthesia induction
|
Not able to intubate the patient
|
2 minutes after anesthesia induction
|
|
Intubation duration
Time Frame: 2 minutes after anesthesia induction
|
Time elapsed from entring the blade between the teeth to detecting an entidal carbondioxide trace
|
2 minutes after anesthesia induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentil of glottic opening score
Time Frame: 2 minutes after anesthesia induction
|
the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the inter-arytenoid notch
|
2 minutes after anesthesia induction
|
|
Cormack lehanne score
Time Frame: 2 minutes after anesthesia induction
|
grade 1 being a full view of the glottis, grade 2 being a partial view, grade 3 being only a view of the epiglottis, and grade 4 being an absent view of the glottis and epiglottis
|
2 minutes after anesthesia induction
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dilek Yazıcıoğlu Ünal, professor, Ankara Etlik City Hospital
Publications and helpful links
General Publications
- Xia M, Jin C, Zheng Y, Wang J, Zhao M, Cao S, Xu T, Pei B, Irwin MG, Lin Z, Jiang H. Deep learning-based facial analysis for predicting difficult videolaryngoscopy: a feasibility study. Anaesthesia. 2024 Apr;79(4):399-409. doi: 10.1111/anae.16194. Epub 2023 Dec 13.
- O'Loughlin EJ, Swann AD, English JD, Ramadas R. Accuracy, intra- and inter-rater reliability of three scoring systems for the glottic view at videolaryngoscopy. Anaesthesia. 2017 Jul;72(7):835-839. doi: 10.1111/anae.13837. Epub 2017 Mar 24.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Etlik City Hospital
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.
Clinical Trials on Airway Management
-
Bursa City HospitalEmre ULUSOYNot yet recruitingAirway Management | Difficult AirwayTurkey (Türkiye)
-
Royal Hospital, OmanNot yet recruitingDifficult Airway | Obesity Difficult Airway Airway Management
-
Kutahya Health Sciences UniversityCompletedAirway Management | Difficult Airway | Difficult Airway IntubationTurkey (Türkiye)
-
NHS TaysideTerminated
-
Akdeniz University HospitalCompletedAirway Management | Difficult Airway | Obstetric AnesthesiaTurkey (Türkiye)
-
Thomas RivaThe Hospital for Sick Children; Children's Hospital of Philadelphia; Charite... and other collaboratorsRecruitingAirway ManagementUnited States, Australia, Switzerland, Italy, Canada, Germany, Brazil
-
Peking Union Medical College HospitalNot yet recruiting
-
University of MalayaActive, not recruiting
-
Akdeniz UniversityCompletedAirway ManagementTurkey (Türkiye)
-
Tufts Medical CenterActive, not recruitingAirway ManagementUnited States