EasyTube
DeviceInsertion for ventilation
NCT Number: NCT02359630
Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insertion for ventilation
Insertion for ventilation
Time frame: 60 seconds
success of insertion
Time frame: 60 seconds
Recording of duration of ventilation, inspiratory and expiratory minute volumes, oropharyngeal leak pressure, and rate of complications
Time frame: 60 seconds
minute volumes recorded during inspiration or expiration
Time frame: 60 seconds
pressure exerted by the inflatable cuff/balloon on the pharyngeal wall
Time frame: 60 seconds
injury to the mucosa of the mouth, nose, etc.
Time frame: 60 seconds
Anesthesiologists describe the difficulty of insertion.
Medical University of Vienna
Other
The EasyTube® in General Anesthesia: A Multicenter Study Comparing EasyTube and Endotracheal Tube
Acronym: EasyTube
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