Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Insertion for ventilation
Insertion for ventilation
success of insertion
success of insertion
Time frame: 60 seconds
duration of ventilation
Recording of duration of ventilation, inspiratory and expiratory minute volumes, oropharyngeal leak pressure, and rate of complications
Time frame: 60 seconds
inspiratory and expiratory minute volumes
minute volumes recorded during inspiration or expiration
Time frame: 60 seconds
oropharyngeal leak pressure
pressure exerted by the inflatable cuff/balloon on the pharyngeal wall
Time frame: 60 seconds
rate of complications
injury to the mucosa of the mouth, nose, etc.
Time frame: 60 seconds
rating of insertion difficulty
Anesthesiologists describe the difficulty of insertion.
Time frame: 60 seconds
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