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

NCT06213389 | Completed DMC

• 1 other identifier: 2023/1011
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation; Difficult or Failed; Airway Complication of Anesthesia

Keywords

Intubation; Difficult; Airway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intubation failure

  Approximately 1 year

• Attempted intubation

  Approximately 1 year

• Intubation time

  Approximately 1 year

• Ease of intubation

  Approximately 1 year

Study Arms (2)

Patients to entubate with EzVision® videolaryngoscopy

EXPERIMENTAL

Patients will intubate with EzVision® videolaryngoscopy

Device: EzVision® videolaryngoscopy

Patients to intubate with Macintosh blade

OTHER

Patients will intubate with Macintosh blade

Device: Macintosh Blade

Interventions

EzVision® videolaryngoscopy DEVICE

Patient will be intubated with EzVision® videolaryngoscopy

Patients to entubate with EzVision® videolaryngoscopy

Macintosh Blade DEVICE

Patient will be intubated with Macintosh Blade

Patients to intubate with Macintosh blade

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nevsehir Public Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42000, Turkey (Türkiye)

Location

Related 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.

  PMID: 22261795 RESULT

• 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.

  PMID: 1595845 RESULT

• 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.

  PMID: 14585451 RESULT

• 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.

  PMID: 12538218 RESULT

• 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.

  PMID: 28118659 RESULT

• 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.

  PMID: 27844477 RESULT

Related Links

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: January 19, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: November 19, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

TU (1)