Clinical trial NCT01171560: Evaluation of the EZ Blocker
Official title: Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
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
postoperative hoarseness
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time from intubation to ventilation:
timeFrame: 5 minutes
Secondary outcomes:
measure: postoperative sore throat or croakiness
timeFrame: 2 minutes
measure: resistance to dislocation
timeFrame: 10 minutes
measure: Peripheral oxygen saturation (SpO2)
timeFrame: 3 hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital of Vienna
Study officials:
References:
citation: 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.