EZ Blocker Versus Left Sided Double-lumen Tube

Radboud University Medical Center100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

One-lung Ventilation

Placement of double lumen tube for one-lung ventilationDEVICE

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.

Placement of EZ- Blocker for one-lung ventilationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

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.

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