Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06213389
Enrollment
70
Registered
2024-01-19
Start date
2023-05-01
Completion date
2024-11-19
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation; Difficult or Failed, Airway Complication of Anesthesia

Keywords

Intubation, Difficult, Airway

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.

Interventions

DEVICEEzVision® videolaryngoscopy

Patient will be intubated with EzVision® videolaryngoscopy

Patient will be intubated with Macintosh Blade

Sponsors

Nevsehir Public Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glottis viewingApproximately 1 yearGlottical 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

Secondary

MeasureTime frameDescription
Attempted intubationApproximately 1 yearAttempted intubation: defined as inserting the endotracheal tube into the oral cavity to perform endotracheal intubation (Wang HE, Garza AG)
Intubation timeApproximately 1 yearIntubation 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.
Intubation failureApproximately 1 yearIntubation 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
Ease of intubationApproximately 1 yearEase 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026