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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-11-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Intubation; Difficult or Failed Airway Complication of Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients to entubate with EzVision® videolaryngoscopy

Patients will intubate with EzVision® videolaryngoscopy

Group Type EXPERIMENTAL

EzVision® videolaryngoscopy

Intervention Type DEVICE

Patient will be intubated with EzVision® videolaryngoscopy

Patients to intubate with Macintosh blade

Patients will intubate with Macintosh blade

Group Type OTHER

Macintosh Blade

Intervention Type DEVICE

Patient will be intubated with Macintosh Blade

Interventions

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EzVision® videolaryngoscopy

Patient will be intubated with EzVision® videolaryngoscopy

Intervention Type DEVICE

Macintosh Blade

Patient will be intubated with Macintosh Blade

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes