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

Endobronchial EZ-Blocker Compared to Left Sided Double-Lumen Tube for One-Lung Ventilation - EZ Blocker vs. LDLT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34895

Enrollment

100

Registered

2010-02-16

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

one-lung ventilation

Interventions

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 e

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)