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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endotracheal intubation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from intubation to ventilation: | is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ? | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative sore throat or croakiness | Documentation of sore throat and croakiness by questioning the patients the day after surgery | 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? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kurt Rützler, M.D. | Contact | 00436643855257 | kurt.ruetzler@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Vienna | Recruiting | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21493621 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 27, 2010 | |
| Reset | Oct 18, 2010 | |
| Release | May 3, 2011 | |
| Reset | Jun 3, 2011 | |
| Release | Jun 8, 2011 | |
| Reset | Jun 30, 2011 | |
| Release | Dec 5, 2011 | |
| Reset | Jan 9, 2012 | |
| Release | Mar 25, 2014 | |
| Reset | Apr 24, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 27, 2010 | Oct 18, 2010 | |||
| May 3, 2011 |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| 10 minutes |
| Peripheral oxygen saturation (SpO2) | Decrease of Peripheral oxygen saturation (SpO2) (in min) under 90% during the hole surgery | 3 hours |
| Jun 3, 2011 |
| Jun 8, 2011 | Jun 30, 2011 |
| Dec 5, 2011 | Jan 9, 2012 |
| Mar 25, 2014 | Apr 24, 2014 |