Multicenter Study of EasyTube® Compared to Endotracheal Tube in General Anesthesia

Study Overview
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Brief Summary
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Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.

Detailed Description
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There is a recent paper suggesting that general anesthesia with the EzT is feasible and by no means worse than anesthesia with a conventional ETT, and there is little but growing evidence that narcosis with this SAD can be continued during general anesthesia. This brings up several potential benefits: The larger balloons of the EzT are less traumatic to the mucosal tissue compared to a conventional ETT or to a laryngeal mask. Since the insertion of the EzT can be performed without using a laryngoscope, this also reduces tissue damage and tooth injuries caused by a laryngoscope. Also, It has been demonstrated that a similar SAD - the Combitube - can be placed by anesthesiologists with relatively little formal training and that ventilation during elective surgery is feasible. However, such detailed data are missing for the EzT, with only smaller, monocenter-studies available. The next logical step was therefore to systematically evaluate the EzT beyond its purpose as a rescue device in a prospective, randomized multicenter-study to evaluate the use of the EzT in comparison with the ETT during general anesthesia. Methods 400 patients with ASA status I-II scheduled for elective surgery in 4 centers were randomized to either the EzT group (n=200) or the ETT group (n=200).

Official Title
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The EasyTube® in General Anesthesia: A Multicenter Study Comparing EasyTube and Endotracheal Tube

Conditions
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Airway Morbidity

Intervention / Treatment
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* Device: EasyTube
* Device: Endotracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I or II and were scheduled for an elective surgery requiring general anesthesia Exclusion Criteria: Age < 18 years Acute or chronic lung disease Patients presenting with sore throat Known esophageal disease Oropharyngeal abnormalities Patients with a cervical spine disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EasyTube<br>Use of EasyTube during general anesthesia | Device: EasyTube<br>* Insertion for ventilation<br>Device: Endotracheal tube<br>* Insertion for ventilation<br>|
| Experimental: Endotracheal tube<br>Use of endotrachel tube during general anesthesia | Device: EasyTube<br>* Insertion for ventilation<br>Device: Endotracheal tube<br>* Insertion for ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of insertion | success of insertion | 60 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of ventilation | Recording of duration of ventilation, inspiratory and expiratory minute volumes, oropharyngeal leak pressure, and rate of complications | 60 seconds | 
| inspiratory and expiratory minute volumes | minute volumes recorded during inspiration or expiration | 60 seconds | 
| oropharyngeal leak pressure | pressure exerted by the inflatable cuff/balloon on the pharyngeal wall | 60 seconds | 
| rate of complications | injury to the mucosa of the mouth, nose, etc. | 60 seconds | 
| rating of insertion difficulty | Anesthesiologists describe the difficulty of insertion. | 60 seconds |