Multicenter Study of EasyTube® Compared to Endotracheal Tube in General Anesthesia
Study Details
Study Description
Brief Summary
Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: EasyTube Use of EasyTube during general anesthesia |
Device: EasyTube
Insertion for ventilation
Device: Endotracheal tube
Insertion for ventilation
|
| Experimental: Endotracheal tube Use of endotrachel tube during general anesthesia |
Device: EasyTube
Insertion for ventilation
Device: Endotracheal tube
Insertion for ventilation
|
Outcome Measures
Primary Outcome Measures
- success of insertion [60 seconds]
success of insertion
Secondary Outcome Measures
- duration of ventilation [60 seconds]
Recording of duration of ventilation, inspiratory and expiratory minute volumes, oropharyngeal leak pressure, and rate of complications
- inspiratory and expiratory minute volumes [60 seconds]
minute volumes recorded during inspiration or expiration
- oropharyngeal leak pressure [60 seconds]
pressure exerted by the inflatable cuff/balloon on the pharyngeal wall
- rate of complications [60 seconds]
injury to the mucosa of the mouth, nose, etc.
- rating of insertion difficulty [60 seconds]
Anesthesiologists describe the difficulty of insertion.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Michael Frass, MD, Medical University of Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10