Endobronchial EZ-Blocker Compared to Left Sided Double-Lumen Tube for One-Lung Ventilatio

Phase 4

Completed

Conditions: one-lung ventilation
10038737

Registration Number: NL-OMON34895

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Contraindications are lesions along the path of the left sided dubble lumen tube or the EZB, tracheal or mainstem bronchial stenosis and distorted carinal anatomy, anticipated difficult intubation (Mallampatti score >= 3) and history or presence of tracheostoma. Excluded are patients who require absolute lung separation or sleeve resection of mainstem bronchus.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the incidence of malposition of a left sided DLT or<br /><br>the EZB. There are four time points were malposition are considered:<br /><br>- Malposition detected by fiber optic bronchoscopy after blind insertion of the<br /><br>device<br /><br>- Malposition detected by fiber optic bronchoscopy or ausculation after<br /><br>inflation of the bronchial cuff of the DLT or the balloon of the EZB (left and<br /><br>right)<br /><br>- Malposition detected by fiber optic bronchoscopy or auscultation after<br /><br>repositioning the patient to lateral decubitus position (after inflation of the<br /><br>bronchial cuff of the DLT or the balloon of the EZB (left and right))<br /><br>- Malposition detected by fiber optic bronchoscopy or visual inspection of the<br /><br>lung by the surgeon during surgery (Dislocation of the device)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are the ease and duration of insertion, the ease and<br /><br>duration of positioning and the quality and the duration of lung deflation.<br /><br><br /><br>The ease of insertion of the devices is qualitative variable: 1= excellent, 2=<br /><br>good, 3=average, 4=poor. If the insertion excellent, it can be explained why.<br /><br><br /><br>The quality of lung deflation is a qualitative variable, judged by the surgeon:<br /><br>1= excellent, 2= good, 3=average, 4=poor. If the lung deflation is not<br /><br>excellent it can be explained why.<br /><br><br /><br>Other secondary parameters are the incidence of postoperative complains of sore<br /><br>throat and hoarseness, and a description of damage to laryngeal, tracheal and<br /><br>bronchial structures. </p><br>