Clinical trial NCT01073722: EZ Blocker Versus Left Sided Double-lumen Tube
Official title: Endobronchial EZ Blocker Compared to Left Sided Double-lumen Tube for One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: One-lung Ventilation
Keywords: thoracic surgery
one-lung ventilation
double lumen tube
endobronchial blocker
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: the incidence of malposition of a left sided DLT or the EZB
timeFrame: 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:
measure: description of damage to laryngeal, tracheal and bronchial structures
timeFrame: 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
measure: the ease of insertion
timeFrame: 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.
measure: the incidence of postoperative complains of sore throat and hoarseness
timeFrame: questionnaire (2 questions, time frame is 1 min) after surgery and one day after surgery
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of Anesthesiology, Pain and Palliative Medicine of the Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Department of anesthesiology, pain and palliative medicine of the Radboud University Nijmegen Medial Center
name: Jo Mourisse, Dr.
role: PRINCIPAL_INVESTIGATOR
References: