EZ Blocker Versus Left Sided Double-lumen Tube

NCT01073722 | Completed Phase 4

• 1 other identifier: NL30799,091,09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

One-lung Ventilation

Keywords

thoracic surgery; one-lung ventilation; double lumen tube; endobronchial blocker

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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.

• 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

Study Arms (2)

Left double lumen tube

ACTIVE COMPARATOR

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

EZ-blocker

ACTIVE COMPARATOR

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

Interventions

Placement of double lumen tube for one-lung ventilation DEVICE

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.

Also known as: Broncho-cath (Mallinckrodt)

Left double lumen tube

Placement of EZ- Blocker for one-lung ventilation DEVICE

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.

Also known as: EZ-blocker (AnaesthetIQ BV, Rotterdam, The Netherlands)

EZ-blocker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Anesthesiology, Pain and Palliative Medicine of the Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Interventions

One-Lung Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics

Study Officials

• Jo Mourisse, Dr.

  Department of anesthesiology, pain and palliative medicine of the Radboud University Nijmegen Medial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 23, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 2, 2011

Record last verified: 2010-08

Locations

NL (1)