Airway MorbidityTUBENCT04158271
Evaluation of Techniques for Tracheal Tube Exchange in Standard and Critical Care Patients
A study testing Prone Position, Laryngeal tube and Endotracheal tube Leackage in people with Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
A randomized controlled study to evaluate different Techniques and Approachs for the Exchange of a tracheal tube or supraglottic airway device in a Simulator Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Prone Position, Laryngeal tube and Endotracheal tube Leackage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 22 Nov 2019to 23 Dec 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- residents and consultans of the Department of Anesthesiology
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
A randomized controlled study to evaluate different Techniques and Approachs for the Exchange of a tracheal tube or supraglottic airway device in a Simulator
Read the detailed description
Exchanging a tracheal tube (ETT) in the high-risk difficult airway patient carries the risk of hypoxemia and the potential of a lost airway. Maintaining continuous airway access during the exchange by incorporating an airway exchange catheter (AEC) or similar device may reliably lessen exchange risk, especially in the known or suspected difficult airway patient, by providing a conduit to facilitate ETT passage into the trachea. We evaluated some approven / etablished techniques in a Simulator based study design.
- Conditions
- Airway Morbidity
- Being tested
- Prone Position, Laryngeal tube, Endotracheal tube Leackage
- Keywords
- Airway Management, Tube Exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositionDevice
In a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position
Laryngeal tubeDevice
In a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube
Endotracheal tube LeackageDevice
In a randomized order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage
| Study group | Role | What they receive |
|---|---|---|
| Prone Position | Experimental | Evaluation of Techniques for tracheal tube Exchange in prone position Receives: Device: Prone Position; Device: Laryngeal tube; Device: Endotracheal tube Leackage |
| Laryngeal tube | Experimental | Evaluation of Techniques for tracheal tube Exchange in patients with laryngeal tube (LT) Receives: Device: Prone Position; Device: Laryngeal tube; Device: Endotracheal tube Leackage |
| Endotracheal tube Leackage | Experimental | Evaluation of Techniques for tracheal tube Exchange in critical care patients with a endotracheal tube and a high leackage Receives: Device: Prone Position; Device: Laryngeal tube; Device: Endotracheal tube Leackage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Strategies for Securing the Airway
Evaluation of Strategies for securing the Airway in patients in the OR and Critical Care Medicine. Participants are confronted with three airway scenarios and perform in a Simulator different airway management strategies.
Measured: through study completion, an average of 10 minutes
Secondary outcomes (3)
Time for intervention
time for Exchange the Primary airway device
Measured: through study completion, an average of 10 minutes
Anaesthesia Experience
individual anaesthesia experience
Measured: through study completion, an average of 10 minutes
IDS
after the Scenario we calculate the Intubation difficult score (IDS)
Measured: through study completion, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start22 Nov 2019
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University Medical Center of Johannes Gutenberg-University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158271
- Sponsor's protocol ID
- JohannesGUU
- Acronym
- TUBE
- Status last verified
- Dec 2019
- First submitted
- 4 Nov 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Techniques for Tracheal Tube Exchange in Standard and Critical Care Patients
- ClinicalTrials.gov ID
- NCT04158271
- Acronym / sponsor ID
- TUBE / JohannesGUU
- Conditions
- Airway Morbidity
- Keywords
- Airway Management, Tube Exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 8 Nov 2019 (actual)
- 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.
A randomized controlled study to evaluate different Techniques and Approachs for the Exchange of a tracheal tube or supraglottic airway device in a Simulator
Detailed description
Exchanging a tracheal tube (ETT) in the high-risk difficult airway patient carries the risk of hypoxemia and the potential of a lost airway. Maintaining continuous airway access during the exchange by incorporating an airway exchange catheter (AEC) or similar device may reliably lessen exchange risk, especially in the known or suspected difficult airway patient, by providing a conduit to facilitate ETT passage into the trachea. We evaluated some approven / etablished techniques in a Simulator based study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prone Position | Experimental | Device: Prone Position, Device: Laryngeal tube, Device: Endotracheal tube LeackageEvaluation of Techniques for tracheal tube Exchange in prone position |
| Laryngeal tube | Experimental | Device: Prone Position, Device: Laryngeal tube, Device: Endotracheal tube LeackageEvaluation of Techniques for tracheal tube Exchange in patients with laryngeal tube (LT) |
| Endotracheal tube Leackage | Experimental | Device: Prone Position, Device: Laryngeal tube, Device: Endotracheal tube LeackageEvaluation of Techniques for tracheal tube Exchange in critical care patients with a endotracheal tube and a high leackage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- residents and consultans of the Department of Anesthesiology
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Prone PositionIn a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position | Device | Endotracheal tube Leackage, Laryngeal tube, Prone Position |
| Laryngeal tubeIn a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube | Device | Endotracheal tube Leackage, Laryngeal tube, Prone Position |
| Endotracheal tube LeackageIn a randomized order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage | Device | Endotracheal tube Leackage, Laryngeal tube, Prone Position |
Primary outcome
Evaluation of Strategies for Securing the Airway
Time frame: through study completion, an average of 10 minutes
Evaluation of Strategies for securing the Airway in patients in the OR and Critical Care Medicine. Participants are confronted with three airway scenarios and perform in a Simulator different airway management strategies.
3 secondary outcomes
Time for intervention
Time frame: through study completion, an average of 10 minutes
Anaesthesia Experience
Time frame: through study completion, an average of 10 minutes
IDS
Time frame: through study completion, an average of 10 minutes
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 24 Dec 2019.
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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.
Marc Kriege, MD principal investigator
University Medical Center of Johannes Gutenberg-University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Position, Laryngeal tube and Endotracheal tube Leackage in people with Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 1 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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Evaluation of Strategies for Securing the Airway (time frame: through study completion, an average of 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2019.