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

Phase 4

Completed

• Conditions: Lung Separation Techniques; One-Lung Ventilation
• Interventions: Device: Mallinckrodt™ Endobronchial Tube; Device: Fuji Uniblocker™; Device: ETView VivaSight™-SL+EB; Device: COOK© Arndt Endobronchial Blocker

• Registration Number: NCT02912598
• Lead Sponsor: Otto-von-Guericke University Magdeburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-09
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Study First Posted: 2016-09-23
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mallinckrodt™ Endobronchial Tube	Mallinckrodt™ Endobronchial Tube	Usage of a left-sided Mallinckrodt™ double-lumen tube (DLT) to achieve lung isolation and one lung ventilation.
Fuji Uniblocker™	Fuji Uniblocker™	Usage of a Fuji Uniblocker™ in a generic single-lumen tube to achieve lung isolation and one lung ventilation.
ETView VivaSight™-SL+EB	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.
COOK© Arndt Endobronchial Blocker	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.

Primary Outcome Measures

Name	Time	Method
Time to initial lung isolation	intraoperative	Duration of initial bronchoscopy-guided placement of the endobronchial ballon. Start: Beginning of direct laryngoscopy. End: Initial inflation of the endobronchially placed cuff.

Secondary Outcome Measures

Name	Time	Method
Ease of placement [numerical rating scale]	intraoperative	Evaluation of difficulty of endobronchial device placement by the anaesthetist.
Oxygenation	intraoperative	Measurement of arterial partial pressure of oxygen by blood gas analysis taken 5min and 15min after establishment of one-lung ventilation.
Bronchoscopies	intraoperative	Number of additional bronchoscopies required after initial placement resulting from suspected or actual dislocations.
Rate of dislocation	intraoperative	Number of device dislocations after correct initial placement. Measurement time point after termination of one-lung ventilation.
Quality of surgical exposure [numerical rating scale]	intraoperative	Surgeon's grading of the quality of surgical exposure resulting from lung deflation. Time point is initial view of the thoracic cavity after pleural incision.