EZ Blocker Versus Left Sided Double-lumen Tube

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01073722
First received: February 17, 2010
Last updated: April 29, 2011
Last verified: August 2010
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Endobronchial EZ Blocker Compared to Left Sided Double-lumen Tube for One-lung Ventilation

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073722

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

No publications provided

Responsible Party: Dr. J.M.J. Mourisse, Radboud University Nijmegen Medical Center
ClinicalTrials.gov Identifier: NCT01073722     History of Changes
Other Study ID Numbers: NL30799,091,09
Study First Received: February 17, 2010
Last Updated: April 29, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on July 20, 2014