Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy

Intubation; Difficult or Failed Clinical Trial

Official title:

Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy in Patients Considering Difficult Intubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213389
• Other study ID #: 2023/1011
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Nevsehir Public Hospital
• Contact: Mehmet Akif Yazar, associate professor
• Phone: +905055665758
• Email: makifyazar[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Intubation; Difficult or Failed

Intervention

Device:
• EzVision® videolaryngoscopy
Patient will be intubated with EzVision® videolaryngoscopy
• Macintosh Blade
Patient will be intubated with Macintosh Blade

Locations

Country	Name	City	State
Turkey	Konya City Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Nevsehir Public Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

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) G — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

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