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Evaluation of the EZ Blocker

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01171560
First received: July 27, 2010
Last updated: August 11, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Intubation
Thoracic Surgery
One-lung Ventilation
 Procedure: endotracheal intubation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Time from intubation to ventilation: [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?


Secondary Outcome Measures:
  • postoperative sore throat or croakiness [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
    Documentation of sore throat and croakiness by questioning the patients the day after surgery

  • resistance to dislocation [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    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?

  • Peripheral oxygen saturation (SpO2) [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
    Decrease of Peripheral oxygen saturation (SpO2) (in min) under 90% during the hole surgery


Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EZ Blocker
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.
 Procedure: endotracheal intubation
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.
Active Comparator: Double lumen tube
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.
 Procedure: endotracheal intubation
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171560

Contacts
Contact: Kurt Rützler, M.D. 00436643855257 kurt.ruetzler@meduniwien.ac.at

Locations
Austria
General Hospital of Vienna Recruiting
Vienna, Austria, 1090
Contact: Kurt Rützler, M.D.         kurt.ruetzler@meduniwien.ac.at    
Principal Investigator: Kurt Rützler, M.D.            
Sub-Investigator: Georg Grubhofer, Prof.            
Sub-Investigator: Helmut Hager, M.D.            
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Department of Cardio-, Thoracic- and Vascular- Anesthesia, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01171560     History of Changes
Other Study ID Numbers: 096/2010
Study First Received: July 27, 2010
Last Updated: August 11, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
EZ Blocker
Double-lumen Tube
Airway
thoracic surgery
time for intubation
 blind insertion
conditions of surgery
postoperative sore throat
postoperative hoarseness

ClinicalTrials.gov processed this record on May 19, 2013