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

The aim of this study is to compare the EzVision® videoryngoscope with conventional laryngoscopy using a Macintosh blade in patients with suspected difficult intubation. This study primarily aims to test the hypothesis that laryngoscopy image is better with EzVision® videoryngoscopy compared to direct laryngoscopy. The secondary hypothesis is also to test the view that, compared to direct laryngoscopy, EzVision® videolingoscopy will improve intubation success, reduce intubation attempts, shorten intubation time, facilitate intubation, and cause less additional complications such as bleeding or sore throat.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Intubation; Difficult or Failed
• Intervention / Treatment: Device: EzVision® videolaryngoscopy; Device: Macintosh Blade

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42000
    • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18 to 65 years old;
2. American Association of Anesthesiologists (ASA) physical condition I-II-III;
3. Elective surgery requiring oral endotracheal intubation for general anesthesia;
4. Compliance with one of the difficult intubation estimation criteria (if more than one)
5. Expected extubation in the operating room

Exclusion Criteria:

1. Refusal to participate in research;
2. Age <18 and >65
3. ASA IV and above
4. Emergency cases
5. Body Mass Index (BMI) > 40 kg/m2.
6. Pregnancy
7. Cardiac surgery
8. Unexpectedly difficult intubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients to entubate with EzVision® videolaryngoscopy; Patients will intubate with EzVision® videolaryngoscopy	Device: EzVision® videolaryngoscopy; Patient will be intubated with EzVision® videolaryngoscopy
Other: Patients to intubate with Macintosh blade; Patients will intubate with Macintosh blade	Device: 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	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	Intubation failure: It is defined as intubation failure if one of the following occurs: Failure to intubate despite three intubation attempts,; Situation that requires replacement of the intubation device,; Difficulty with intubation that will stop working at the discretion of the anesthesiologist	Approximately 1 year
Attempted intubation	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	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	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: Nevsehir Public Hospital

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

• Related Info
• Related Info
• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Intubation; Airway; Difficult
• Other Study ID Numbers: 2023/1011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No