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

Airway Morbidity Clinical Trial

— EasyTube  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359630
• Other study ID #: 10
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2015
• Last updated: May 8, 2017
• Start date: January 2005
• Est. completion date: February 2007

Study information

• Verified date: May 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• EasyTube
Insertion for ventilation
• Endotracheal tube
Insertion for ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of insertion	success of insertion	60 seconds
Secondary	duration of ventilation	Recording of duration of ventilation, inspiratory and expiratory minute volumes, oropharyngeal leak pressure, and rate of complications	60 seconds
Secondary	inspiratory and expiratory minute volumes	minute volumes recorded during inspiration or expiration	60 seconds
Secondary	oropharyngeal leak pressure	pressure exerted by the inflatable cuff/balloon on the pharyngeal wall	60 seconds
Secondary	rate of complications	injury to the mucosa of the mouth, nose, etc.	60 seconds
Secondary	rating of insertion difficulty	Anesthesiologists describe the difficulty of insertion.	60 seconds