Lung Separation Techniques, One-Lung Ventilation
Conditions
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.
Interventions
DEVICEMallinckrodt™ Endobronchial Tube
DEVICEFuji Uniblocker™
DEVICEETView VivaSight™-SL+EB
DEVICECOOK© Arndt Endobronchial Blocker
Sponsors
Otto-von-Guericke University Magdeburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ease of placement [numerical rating scale] | intraoperative | Evaluation of difficulty of endobronchial device placement by the anaesthetist. |
| 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. |
| 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. |
Outcome results
None listed