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

Lung Isolation in Thoracic Surgery - a Comparison of the VivaSight™ EB Endobronchial Blocker With Established Devices

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of placement [numerical rating scale]	Evaluation of difficulty of endobronchial device placement by the anaesthetist.	intraoperative
Rate of dislocation	Number of device dislocations after correct initial placement. Measurement time point after termination of one-lung ventilation.	intraoperative
Quality of surgical exposure [numerical rating scale]	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.	intraoperative
Oxygenation	Measurement of arterial partial pressure of oxygen by blood gas analysis taken 5min and 15min after establishment of one-lung ventilation.	intraoperative
Bronchoscopies	Number of additional bronchoscopies required after initial placement resulting from suspected or actual dislocations.	intraoperative

Collaborators and Investigators

• Sponsor: Otto-von-Guericke University Magdeburg
• Investigators: Study Chair: Thomas Hachenberg, Prof. Dr. med., Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 23, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 142/14