EZ Blocker Versus Left Sided Double-lumen Tube

One-lung Ventilation Clinical Trial

Official title:

Endobronchial EZ Blocker Compared to Left Sided Double-lumen Tube for One-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073722
• Other study ID #: NL30799,091,09
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2010
• Last updated: April 29, 2011
• Start date: February 2010
• Est. completion date: April 2011

Study information

• Verified date: August 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• One-lung Ventilation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Department of Anesthesiology, Pain and Palliative Medicine of the Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of malposition of a left sided DLT or the EZB		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	No
Secondary	description of damage to laryngeal, tracheal and bronchial structures		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	Yes
Secondary	the ease of insertion		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.	No
Secondary	the incidence of postoperative complains of sore throat and hoarseness		questionnaire (2 questions, time frame is 1 min) after surgery and one day after surgery	No