Airway MorbidityPhase 3EasyTubeNCT02359630
Multicenter Study of EasyTube® Compared to Endotracheal Tube in General Anesthesia
A Phase 3 study testing EasyTube and Endotracheal tube in people with Airway Morbidity, run by Medical University of Vienna.
Trial summary
Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- EasyTube and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Feb 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II and were scheduled for an elective surgery requiring general anesthesia
Who cannot join
- Age < 18 years
- Acute or chronic lung disease
- Patients presenting with sore throat
- Known esophageal disease
- Oropharyngeal abnormalities
- Patients with a cervical spine disease
About this study
Official title: The EasyTube® in General Anesthesia: A Multicenter Study Comparing EasyTube and Endotracheal Tube
Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.
Read the 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).
- Conditions
- Airway Morbidity
- Being tested
- EasyTube, Endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasyTubeDevice
Insertion for ventilation
Endotracheal tubeDevice
Insertion for ventilation
| Study group | Role | What they receive |
|---|---|---|
| EasyTube | Active comparator | Use of EasyTube during general anesthesia Receives: Device: EasyTube; Device: Endotracheal tube |
| Endotracheal tube | Experimental | Use of endotrachel tube during general anesthesia Receives: Device: EasyTube; Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of insertion
success of insertion
Measured: 60 seconds
Secondary outcomes (5)
duration of ventilation
Recording of duration of ventilation, inspiratory and expiratory minute volumes, oropharyngeal leak pressure, and rate of complications
Measured: 60 seconds
inspiratory and expiratory minute volumes
minute volumes recorded during inspiration or expiration
Measured: 60 seconds
oropharyngeal leak pressure
pressure exerted by the inflatable cuff/balloon on the pharyngeal wall
Measured: 60 seconds
rate of complications
injury to the mucosa of the mouth, nose, etc.
Measured: 60 seconds
rating of insertion difficulty
Anesthesiologists describe the difficulty of insertion.
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Frass, Medical University of Vienna
- Investigators
- Michael Frass, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359630
- Sponsor's protocol ID
- 10
- Acronym
- EasyTube
- Status last verified
- May 2017
- First submitted
- 18 Jan 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11135725
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EasyTube® in General Anesthesia: A Multicenter Study Comparing EasyTube and Endotracheal Tube
- ClinicalTrials.gov ID
- NCT02359630
- Acronym / sponsor ID
- EasyTube / 10
- Conditions
- Airway Morbidity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EasyTube | Active comparator | Device: EasyTube, Device: Endotracheal tubeUse of EasyTube during general anesthesia |
| Endotracheal tube | Experimental | Device: EasyTube, Device: Endotracheal tubeUse of endotrachel tube during general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I or II and were scheduled for an elective surgery requiring general anesthesia
Key exclusion criteria (6 listed)
- Age < 18 years
- Acute or chronic lung disease
- Patients presenting with sore throat
- Known esophageal disease
- Oropharyngeal abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EasyTubeInsertion for ventilation | Device | EasyTube, Endotracheal tube |
| Endotracheal tubeInsertion for ventilation | Device | EasyTube, Endotracheal tube |
Primary outcome
success of insertion
Time frame: 60 seconds
success of insertion
5 secondary outcomes
duration of ventilation
Time frame: 60 seconds
inspiratory and expiratory minute volumes
Time frame: 60 seconds
oropharyngeal leak pressure
Time frame: 60 seconds
rate of complications
Time frame: 60 seconds
rating of insertion difficulty
Time frame: 60 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Results publication: PubMed 11135725Gaitini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Frass, MD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EasyTube and Endotracheal tube in people with Airway Morbidity, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of insertion (time frame: 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.