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

Otto-von-Guericke University Magdeburg

Status and phase: Completed; Phase 4

Conditions: One-Lung Ventilation; Lung Separation Techniques

Treatments: Device: Fuji Uniblocker™; Device: ETView VivaSight™-SL+EB; Device: COOK© Arndt Endobronchial Blocker; Device: Mallinckrodt™ Endobronchial Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02912598

142/14

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 4 patient groups

Mallinckrodt™ Endobronchial Tube

Active Comparator group

Description:

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

Treatment:

Device: Mallinckrodt™ Endobronchial Tube

Fuji Uniblocker™

Active Comparator group

Description:

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

Treatment:

Device: Fuji Uniblocker™

ETView VivaSight™-SL+EB

Experimental group

Description:

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

Treatment:

Device: ETView VivaSight™-SL+EB

COOK© Arndt Endobronchial Blocker

Active Comparator group

Description:

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

Treatment:

Device: COOK© Arndt Endobronchial Blocker