Clinical trial NCT02912598: Lung Isolation in Thoracic Surgery - a Randomized Trial Comparing the VivaSight™ EB Endobronchial Blocker With Established Devices
Official title: Lung Isolation in Thoracic Surgery - a Comparison of the VivaSight™ EB Endobronchial Blocker With Established Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Separation Techniques
One-Lung Ventilation
Lead sponsor: Otto-von-Guericke University Magdeburg
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to initial lung isolation
timeFrame: intraoperative
Secondary outcomes:
measure: Ease of placement [numerical rating scale]
timeFrame: intraoperative
measure: Rate of dislocation
timeFrame: intraoperative
measure: Quality of surgical exposure [numerical rating scale]
timeFrame: intraoperative
measure: Oxygenation
timeFrame: intraoperative
measure: Bronchoscopies
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R.
name: Thomas Hachenberg, Prof. Dr. med.
role: STUDY_CHAIR
References: