NCT02359630

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Airway Morbidity

Interventions

Type	Name	Description
DEVICE	EasyTube	Insertion for ventilation
DEVICE	Endotracheal tube	Insertion for ventilation

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2015-02-10
• Last updated: 2017-05-09