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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mallinckrodt™ Endobronchial Tube | Active Comparator | Usage of a left-sided Mallinckrodt™ double-lumen tube (DLT) to achieve lung isolation and one lung ventilation. |
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| Fuji Uniblocker™ | Active Comparator | Usage of a Fuji Uniblocker™ in a generic single-lumen tube to achieve lung isolation and one lung ventilation. |
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| ETView VivaSight™-SL+EB | Experimental | Usage of a ETView VivaSight™-EB endobronchial blocker in a ETView VivaSight™-SL single-lumen tube to achieve lung isolation and one lung ventilation. |
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| COOK© Arndt Endobronchial Blocker | Active Comparator | Usage of a COOK© Arndt Endobronchial Blocker in a generic single-lumen tube to achieve lung isolation and one lung ventilation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mallinckrodt™ Endobronchial Tube | Device |
| ||
| Fuji Uniblocker™ |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Hachenberg, Prof. Dr. med. | Klinik für Anaesthesiologie und Intensivtherapie der Otto-von-Guericke-Universität / Medizinische Fakultät Universitätsklinikum Magdeburg A.ö.R. | Study Chair |
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| Device |
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| ETView VivaSight™-SL+EB | Device |
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| COOK© Arndt Endobronchial Blocker | Device |
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| 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 |