Lung Isolation in Thoracic Surgery - a Randomized Trial Comparing the VivaSight™ EB Endobronchial Blocker With Established Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-11-30

Brief Summary

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Surgery involving the chest cavity, particularly VATS procedures, often require one-lung ventilation. The double-lumen tube (DLT) is considered the gold standard for lung isolation with different models of bronchial blockers (BB) used in special populations and circumstances. Their routine use is impeded by prolonged placement times, frequent malpositionings and higher costs when compared to the DLT, as recently reported in a meta-analysis by Clayton-Smith et al. The VivaSight™ SL+EB as a combination of a single-lumen tube with an integrated camera and a bronchial blocker allows for endobronchial placement without the use of a fiberoptic bronchoscope. An external monitor provides continuous visualization of the tracheal carina and the position of the bronchial cuff. The purpose of this study was to evaluate the clinical performance of the VivaSight™ SL+EB when compared to a left-sided double-lumen tube and established bronchial blockers. The investigators hypothesized a reduction in time to initial lung isolation due to the simplified placement procedure compared to other bronchial blockers. Continuous intraprocedural airway visualization may allow for early detection of dislocations. Necessary repositionings may be possible without additional bronchoscopies, reducing both disruptions of ventilation and maintenance costs.

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Detailed Description

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Conditions

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Lung Separation Techniques One-Lung Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mallinckrodt™ Endobronchial Tube

Usage of a left-sided Mallinckrodt™ double-lumen tube (DLT) to achieve lung isolation and one lung ventilation.

Group Type ACTIVE_COMPARATOR

Mallinckrodt™ Endobronchial Tube

Intervention Type DEVICE

Fuji Uniblocker™

Usage of a Fuji Uniblocker™ in a generic single-lumen tube to achieve lung isolation and one lung ventilation.

Group Type ACTIVE_COMPARATOR

Fuji Uniblocker™

Intervention Type DEVICE

ETView VivaSight™-SL+EB

Usage of a ETView VivaSight™-EB endobronchial blocker in a ETView VivaSight™-SL single-lumen tube to achieve lung isolation and one lung ventilation.

Group Type EXPERIMENTAL

ETView VivaSight™-SL+EB

Intervention Type DEVICE

COOK© Arndt Endobronchial Blocker

Usage of a COOK© Arndt Endobronchial Blocker in a generic single-lumen tube to achieve lung isolation and one lung ventilation.

Group Type ACTIVE_COMPARATOR

COOK© Arndt Endobronchial Blocker

Intervention Type DEVICE

Interventions

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Mallinckrodt™ Endobronchial Tube

Intervention Type DEVICE

Fuji Uniblocker™

Intervention Type DEVICE

ETView VivaSight™-SL+EB

Intervention Type DEVICE

COOK© Arndt Endobronchial Blocker

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age greater than or at 18 years
* scheduled for elective thoracic surgery with one-lung ventilation
* written informed consent in anaesthesia, the study and anonymized data collection

Exclusion Criteria

* necessary conversion between devices
* one-lung ventilation impossible to establish
* denial of the study or data collection
* surgical or anatomical circumstances preventing the use of a double-lumen tube

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No