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

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

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-02-28

Brief Summary

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

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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).

Conditions

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Airway Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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EasyTube

Use of EasyTube during general anesthesia

Group Type ACTIVE_COMPARATOR

EasyTube

Intervention Type DEVICE

Insertion for ventilation

Endotracheal tube

Intervention Type DEVICE

Insertion for ventilation

Endotracheal tube

Use of endotrachel tube during general anesthesia

Group Type EXPERIMENTAL

EasyTube

Intervention Type DEVICE

Insertion for ventilation

Endotracheal tube

Intervention Type DEVICE

Insertion for ventilation

Interventions

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EasyTube

Insertion for ventilation

Intervention Type DEVICE

Endotracheal tube

Insertion for ventilation

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No