IntubationPhase 4NCT01171560
Evaluation of the EZ Blocker
A Phase 4 study testing endotracheal intubation in people with Intubation and Thoracic Surgery, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation, Thoracic Surgery, One-lung Ventilation
- What is being tested?
- endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Aug 2010
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
- thoracic surgery with requiring single lung ventilation in lateral position
- ASA Status 1-3
- Oral and written consent to participation
- Age 18- 90
Who cannot join
- Contraindications against placing a double lume tube, like tracheal lesions, etc.
- Thoracic surgery within the last four weeks
- Any form of infection (Pneumonia, Pleural empyema) or suspected Tbc
- BMI higher than 45
- Patients with a previous diagnoses or suspected difficult airway
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
General Hospital of Vienna
Vienna, State of Vienna, 1090
Kurt Rützler, M.D., kurt.ruetzler@meduniwien.ac.at
Kurt Rützler, M.D.
About this study
Official title: Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®
In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. The double lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the right side of the lung dependant of the model of the tube. Thus it is possible to operate on one collapsed side of the lung while ventilating the other side.
Due to length and stiffness resulting of the construction of the device more side effects than after intubation with a conventional single lumen tube is expected. Possible side effects may be bleeding, swelling, sore throat or croakiness.
Read more
The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a device placing a balloon into one bronchus to be able to provide single lung ventilation like the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional single lume tube after intubation with a hook on one and a balloon on the other distal end. The hook prevents the device from being pushed too far to be able to harm the lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon. The device is easily positioned using a bronchoscope and when the anaesthesiologists confirmed the correct position of the device, the balloon can be inflated and deflated as needed.
Due to the easier approach the investigators expect less side effects as mentioned earlier using the EZ-Blocker compared to the double lume tube. As well the stress caused by intubation may be reduced.
- Conditions
- Intubation, Thoracic Surgery, One-lung Ventilation
- Being tested
- endotracheal intubation
- Keywords
- EZ Blocker, Double-lumen Tube, Airway, thoracic surgery, time for intubation, blind insertion, conditions of surgery, postoperative sore throat, postoperative hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubationProcedure or surgery
The patients will be randomized to one of two groups: EZ Blocker or conventional double lume tube. After induction of anesthesia, intubation using respective device will be performed in dorsal position.
| Study group | Role | What they receive |
|---|---|---|
| EZ Blocker | Active comparator | Patients assigned to the EZ group will be intubated using a conventional tube in an adequate size as it is standard of care and single lung ventilation will be provided using the EZ-Blocker. Receives: Procedure: endotracheal intubation |
| Double lumen tube | Active comparator | The patients assigned to the "double lume tube" group will be intubated using the double lume tube in an adequate size as it is standard of care. Receives: Procedure: endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from intubation to ventilation:
is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?
Measured: 5 minutes
Secondary outcomes (3)
postoperative sore throat or croakiness
Documentation of sore throat and croakiness by questioning the patients the day after surgery
Measured: 2 minutes
resistance to dislocation
Which device, double-lung-tube or EZ-Blocker, is more resistant to dislocation in endotracheal/endobronchial position, especially when the patient is moved from dorsal to lateral position?
Measured: 10 minutes
Peripheral oxygen saturation (SpO2)
Decrease of Peripheral oxygen saturation (SpO2) (in min) under 90% during the hole surgery
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010 (estimated)
- Study completionAug 2010 (estimated)
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 IntubationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171560
- Sponsor's protocol ID
- 096/2010
- Status last verified
- May 2010
- First submitted
- 27 Jul 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruetzler K, Grubhofer G, Schmid W, Papp D, Nabecker S, Hutschala D, Lang G, Hager H. Randomized clinical trial comparing double-lumen tube and EZ-Blocker for single-lung ventilation. Br J Anaesth. 2011 Jun;106(6):896-902. doi: 10.1093/bja/aer086. Epub 2011 Apr 14.
PubMed 21493621
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®
- ClinicalTrials.gov ID
- NCT01171560
- Acronym / sponsor ID
- 096/2010
- Conditions
- Intubation, Thoracic Surgery, One-lung Ventilation
- Keywords
- EZ Blocker, Double-lumen Tube, Airway, thoracic surgery, time for intubation, blind insertion, conditions of surgery, postoperative sore throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 28 Jul 2010 (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.
In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. The double lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the right side of the lung dependant of the model of the tube. Thus it is possible to operate on one collapsed side of the lung while ventilating the other side.
Due to length and stiffness resulting of the construction of the device more side effects than after intubation with a conventional single lumen tube is expected. Possible side effects may be bleeding, swelling, sore throat or croakiness.
The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a device placing a balloon into one bronchus to be able to provide single lung ventilation like the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional single lume tube after intubation with a hook on one and a balloon on the other distal end. The hook prevents the device from being pushed too far to be able to harm the lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon. The device is easily positioned using a bronchoscope and when the anaesthesiologists confirmed the correct position of the device, the balloon can be inflated and deflated as needed.
Due to the easier approach the investigators expect less side effects as mentioned earlier using the EZ-Blocker compared to the double lume tube. As well the stress caused by intubation may be reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EZ Blocker | Active comparator | Procedure: endotracheal intubationPatients assigned to the EZ group will be intubated using a conventional tube in an adequate size as it is standard of care and single lung ventilation will be provided using the EZ-Blocker. |
| Double lumen tube | Active comparator | Procedure: endotracheal intubationThe patients assigned to the "double lume tube" group will be intubated using the double lume tube in an adequate size as it is standard of care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective surgery
- thoracic surgery with requiring single lung ventilation in lateral position
- ASA Status 1-3
- Oral and written consent to participation
- Age 18- 90
Key exclusion criteria (5 listed)
- Contraindications against placing a double lume tube, like tracheal lesions, etc.
- Thoracic surgery within the last four weeks
- Any form of infection (Pneumonia, Pleural empyema) or suspected Tbc
- BMI higher than 45
- Patients with a previous diagnoses or suspected difficult airway
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 |
|---|---|---|
| endotracheal intubationThe patients will be randomized to one of two groups: EZ Blocker or conventional double lume tube. After induction of anesthesia, intubation using respective device will be performed in dorsal position. | Procedure or surgery | Double lumen tube, EZ Blocker |
Primary outcome
Time from intubation to ventilation:
Time frame: 5 minutes
is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?
3 secondary outcomes
postoperative sore throat or croakiness
Time frame: 2 minutes
resistance to dislocation
Time frame: 10 minutes
Peripheral oxygen saturation (SpO2)
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2010.
- Derived from this study: PubMed 21493621Ruetzler K, Grubhofer G, Schmid W, Papp D, Nabecker S, Hutschala D, Lang G, Hager H. Randomized clinical trial comparing double-lumen tube and EZ-Blocker for single-lung ventilation. Br J Anaesth. 2011 Jun;106(6):896-902. doi: 10.1093/bja/aer086. Epub 2011 Apr 14.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing endotracheal intubation in people with Intubation and Thoracic Surgery, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Aug 2010. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kurt Rützler, M.D. (00436643855257, kurt.ruetzler@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from intubation to ventilation: (time frame: 5 minutes). 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 NCT01171560, 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 12 Aug 2010.