Clinical trial NCT02359630: Multicenter Study of EasyTube® Compared to Endotracheal Tube in General Anesthesia
Official title: The EasyTube® in General Anesthesia: A Multicenter Study Comparing EasyTube and Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Airway Morbidity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility 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

Primary outcomes:
measure: success of insertion
timeFrame: 60 seconds
Secondary outcomes:
measure: duration of ventilation
timeFrame: 60 seconds
measure: inspiratory and expiratory minute volumes
timeFrame: 60 seconds
measure: oropharyngeal leak pressure
timeFrame: 60 seconds
measure: rate of complications
timeFrame: 60 seconds
measure: rating of insertion difficulty
timeFrame: 60 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Michael Frass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaitini LA, Vaida SJ, Mostafa S, Yanovski B, Croitoru M, Capdevila MD, Sabo E, Ben-David B, Benumof J. The Combitube in elective surgery: a report of 200 cases. Anesthesiology. 2001 Jan;94(1):79-82. doi: 10.1097/00000542-200101000-00016.