EZ Blocker Versus Left Sided Double-lumen Tube

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073722
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : May 2, 2011
Information provided by:
Radboud University

Brief Summary:
Lung isolation is used to achieve one lung ventilation to facilitate thoracic surgery. Two methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced through a single lumen tube. However, both techniques have advantages and disadvantages. Briefly, the DLT can be positioned faster and remains firmly in place, but is sometimes difficult or even impossible to introduce. The DLT is larger than a conventional single lumen tube and the incidence of postoperative hoarseness and airway injuries is higher. Compared to the DLT, bronchial blocking devices are more difficult to position and need more frequent intraoperative repositioning. These disadvantages of the existing devices for lung isolation prompted further development of the bronchial blocker concept. The design of a new Y shaped bronchial blocker, the EZ- Blocker® (AnaesthetIQ BV, Rotterdam, The Netherlands) (EZB), combines the advantages of both lung isolation techniques. The aim of the study is to compare in a randomised, prospective way the ease of placement, the incidence of malpositioning and the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity of damage to laryngeal, tracheal and bronchial structures caused by the use of the DLT or the EZB is a target of the study.

Condition or disease Intervention/treatment Phase
One-lung Ventilation Device: Placement of double lumen tube for one-lung ventilation Device: Placement of EZ- Blocker for one-lung ventilation Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Endobronchial EZ Blocker Compared to Left Sided Double-lumen Tube for One-lung Ventilation
Study Start Date : February 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Active Comparator: Left double lumen tube
Traditionally, single lung ventilation is obtained with a double lumen tube (DLT). In our institution a polyvinyl DLT (Broncho-cath, Mallinckrodt,) without carinal hook, is used. This type of tube exists of a tube with two lumen with two distal cuffs. One lumen (called the bronchial lumen) extends some distance further, has a slight curvature and has a small blue cuff. The other lumen (called the tracheal lumen) has a larger cuff. A DLT tube exists in four sizes and one can choose in a left or a right configuration. Almost always, we use a left sided DLT. A DLT has a much larger diameter than a standard single lumen endotracheal tube
Device: Placement of double lumen tube for one-lung ventilation
The gold standard for lung isolation is the use of a double lumen tube (DLT). A DLT is a bifurcated tube with a bronchial and a tracheal lumen.
Other Name: Broncho-cath (Mallinckrodt)

Active Comparator: EZ-blocker
The EZ-blocker (EZB) is a semi-rigid catheter but it has two distal extensions, both with an inflatable cuff and a central lumen. It is intended for use in combination with a standard single lumen tube. After the EZB is advanced trough the distal end of the single lumen tube, both extensions spread out and find their way in the left and right main stem bronchi. The place where the two extensions are attached to the shaft now rests on the carina. Fiber optic bronchoscopy should be used for proper positioning. After placement of the EZB, one of the cuffs can be inflated to obtain lung separation under direct visual inspection with fiber optic bronchoscopy.
Device: Placement of EZ- Blocker for one-lung ventilation
Bronchial blockers are balloon-tipped semi-rigid catheters. Different types are available. They are not easy to put in position and frequently dislocates during repositioning of the patient or during surgical manipulation. To solve these problems, a novel type of bronchus blocker, i.e. the EZ- Blocker® is developed. The EZB is also a semi-rigid catheter but it has two distal extensions, both with an inflatable cuff and a central lumen. These improvements owe to the fact that the blocker anchors itself on the carina with the two extensions.
Other Name: EZ-blocker (AnaesthetIQ BV, Rotterdam, The Netherlands)

Primary Outcome Measures :
  1. the incidence of malposition of a left sided DLT or the EZB [ Time Frame: there are four time points (after insertion of the device, after inflation of cuff or balloon, after repositioning patient, during surgery) were malposition are considered. Total time spend is 3 hours on the day of the operation ]

Secondary Outcome Measures :
  1. description of damage to laryngeal, tracheal and bronchial structures [ Time Frame: videobronchoscopy before and after intervention. Time frame 5 min for each video and additional 5 min for assessment afterwards on the day of the operation ]
  2. the ease of insertion [ Time Frame: the ease of insertion of the devices is qualitative variable: 1= excellent, 2= good, 3=average, 4=poor. Time frame is 5 min on the day of the operation. ]
  3. the incidence of postoperative complains of sore throat and hoarseness [ Time Frame: questionnaire (2 questions, time frame is 1 min) after surgery and one day after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA physical status 1-3 patients
  • Patients scheduled for surgery requiring a left sided DLT for single lung ventilation

Exclusion Criteria:

  • Contraindications are lesions along the path of the left sided double lumen tube or the EZB
  • Tracheal or mainstem bronchial stenosis
  • Distorted carinal anatomy,
  • Anticipated difficult intubation (Mallampatti score ≥ 3)
  • History or presence of tracheostoma
  • Patients who require absolute lung separation
  • Patients who require sleeve resection of mainstem bronchus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073722

Department of Anesthesiology, Pain and Palliative Medicine of the Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Principal Investigator: Jo Mourisse, Dr. Department of anesthesiology, pain and palliative medicine of the Radboud University Nijmegen Medial Center

Responsible Party: Dr. J.M.J. Mourisse, Radboud University Nijmegen Medical Center Identifier: NCT01073722     History of Changes
Other Study ID Numbers: NL30799,091,09
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: August 2010

Keywords provided by Radboud University:
thoracic surgery
one-lung ventilation
double lumen tube
endobronchial blocker