- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06213389
Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy
Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy in Patients Considering Difficult Intubation
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Akif Yazar, associate professor
- Phone Number: +905055665758
- Email: makifyazar@hotmail.com
Study Contact Backup
- Name: Ali Aydın Öner, research assistant
- Phone Number: +905325915142
- Email: aliaydinoner@gmail.com
Study Locations
-
-
-
Konya, Turkey, 42000
- Recruiting
- Konya City Hospital
-
Contact:
- Betül Kozanhan, proffessor doctor
- Phone Number: +903323105000
- Email: betulkozanhan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 65 years old;
- American Association of Anesthesiologists (ASA) physical condition I-II-III;
- Elective surgery requiring oral endotracheal intubation for general anesthesia;
- Compliance with one of the difficult intubation estimation criteria (if more than one)
- Expected extubation in the operating room
Exclusion Criteria:
- Refusal to participate in research;
- Age <18 and >65
- ASA IV and above
- Emergency cases
- Body Mass Index (BMI) > 40 kg/m2.
- Pregnancy
- Cardiac surgery
- Unexpectedly difficult intubation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients to entubate with EzVision® videolaryngoscopy
Patients will intubate with EzVision® videolaryngoscopy
|
Patient will be intubated with EzVision® videolaryngoscopy
|
Other: Patients to intubate with Macintosh blade
Patients will intubate with Macintosh blade
|
Patient will be intubated with Macintosh Blade
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glottis viewing
Time Frame: Approximately 1 year
|
Glottical viewing will be measured by Modified Cormack Lehane grading. In this scoring system, number 1 indicates the best appearance, while number 4 indicates the worst situation where the glottis is not visible. This measurement have no specific value, but it evaluates glottis opening as visually. 1. Fill view of the glottis 2a. Partial view of the glottis 2b. Arytenoids or posterior part of the vocal cords only visible 3. Only epiglottis visible 4. Neither glottis nor epiglottis visible |
Approximately 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation failure
Time Frame: Approximately 1 year
|
Intubation failure: It is defined as intubation failure if one of the following occurs:
|
Approximately 1 year
|
Attempted intubation
Time Frame: Approximately 1 year
|
Attempted intubation: defined as inserting the endotracheal tube into the oral cavity to perform endotracheal intubation (Wang HE, Garza AG)
|
Approximately 1 year
|
Intubation time
Time Frame: Approximately 1 year
|
Intubation time: defined as the time between insertion of the laryngoscope into the oral cavity and the first appearance of end-tidal CO2. Ease of intubation: defined as the anesthetist's subjective assessment after finishing the intubation procedure as: (1) very easy; (2) easy; (3) medium; (4) difficult; and (5) impossible. (Ruetzler K) to. |
Approximately 1 year
|
Ease of intubation
Time Frame: Approximately 1 year
|
Ease of intubation: defined as the anesthetist's subjective assessment after finishing the intubation procedure as: (1) very easy; (2) easy; (3) medium; (4) difficult; and (5) impossible.
(Ruetzler K)
|
Approximately 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Butler PJ, Dhara SS. Prediction of difficult laryngoscopy: an assessment of the thyromental distance and Mallampati predictive tests. Anaesth Intensive Care. 1992 May;20(2):139-42. doi: 10.1177/0310057X9202000202.
- Lewis SR, Butler AR, Parker J, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011136. doi: 10.1002/14651858.CD011136.pub2.
- Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34.
- Garza AG, Gratton MC, Coontz D, Noble E, Ma OJ. Effect of paramedic experience on orotracheal intubation success rates. J Emerg Med. 2003 Oct;25(3):251-6. doi: 10.1016/s0736-4679(03)00198-7.
- Khan ZH, Kashfi A, Ebrahimkhani E. A comparison of the upper lip bite test (a simple new technique) with modified Mallampati classification in predicting difficulty in endotracheal intubation: a prospective blinded study. Anesth Analg. 2003 Feb;96(2):595-9, table of contents. doi: 10.1097/00000539-200302000-00053.
- Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023/1011
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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