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

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Airway Morbidity

Treatments: Device: Endotracheal tube; Device: EasyTube

Study type: Interventional

Funder types: Other

Identifiers

NCT02359630

10

Details and patient eligibility

About

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

Full 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).

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

EasyTube

Active Comparator group

Description:

Use of EasyTube during general anesthesia

Treatment:

Device: EasyTube

Device: Endotracheal tube

Endotracheal tube

Experimental group

Description:

Use of endotrachel tube during general anesthesia

Treatment:

Device: EasyTube

Device: Endotracheal tube