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Completed

NCT Number: NCT02359630

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EasyTube

Device

Insertion for ventilation

Endotracheal tube

Device

Insertion for ventilation

Primary outcomes

  1. success of insertion

    Time frame: 60 seconds

    success of insertion

Secondary outcomes

  1. duration of ventilation

    Time frame: 60 seconds

    Recording of duration of ventilation, inspiratory and expiratory minute volumes, oropharyngeal leak pressure, and rate of complications

  2. inspiratory and expiratory minute volumes

    Time frame: 60 seconds

    minute volumes recorded during inspiration or expiration

  3. oropharyngeal leak pressure

    Time frame: 60 seconds

    pressure exerted by the inflatable cuff/balloon on the pharyngeal wall

  4. rate of complications

    Time frame: 60 seconds

    injury to the mucosa of the mouth, nose, etc.

  5. rating of insertion difficulty

    Time frame: 60 seconds

    Anesthesiologists describe the difficulty of insertion.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: EasyTube

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 10, 2015
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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