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EZ Blocker Versus Left Sided Double-lumen Tube

NCT01073722 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-05-02

No results posted yet for this study

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.

Conditions

  • One-lung Ventilation

Interventions

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.

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.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Jo Mourisse, Dr. · Department of anesthesiology, pain and palliative medicine of the Radboud University Nijmegen Medial Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073722 on ClinicalTrials.gov