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

Phase 3

Completed

• Conditions: Airway Morbidity
• Interventions: Device: EasyTube; Device: Endotracheal tube

• Registration Number: NCT02359630
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2015-01-18
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I or II and were scheduled for an elective surgery requiring general anesthesia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EasyTube	EasyTube	Use of EasyTube during general anesthesia
Endotracheal tube	EasyTube	Use of endotrachel tube during general anesthesia
EasyTube	Endotracheal tube	Use of EasyTube during general anesthesia
Endotracheal tube	Endotracheal tube	Use of endotrachel tube during general anesthesia

Primary Outcome Measures

Name	Time	Method
success of insertion	60 seconds	success of insertion

Secondary Outcome Measures

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