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No prospective randomized clinical trial assessed the performance of this new device in a clinical setting. Consequently the aim of this study is to determine clinical performance of this new device compared with conventional DLT.
In several clinical situations and surgical procedures single-lung ventilation (SLV) is essential. Especially during thoracic surgery SLV and collapse of the operated lung, while ventilating the other side of the lung is the most frequented indication. In these cases the double lumen tube (DLT) is the most widely used device.
The DLT consists of a proximal tracheal and a distal bronchial end, reaching into the left or the right side of the lung- dependent of the model of the tube. Endotracheal intubation with DLT, which are much larger and stiffer than conventional single-lumen tubes, are much more difficult to place and are especially likely to provoke airway injuries. Furthermore, placement of a DLT requires obligatory fiberoptic bronchoscopy and a certain level of experience. Tube misplacement after patients removal from dorsal (intubation-) to lateral position as well as during surgical procedure is relatively frequent. Tube displacement from its proper position above the carina, respectively in the main bronchus, may result in life-threating complications and airway lacerations.
The anesthetist may detect tube misplacement from indirect clinical signs including increased airway pressure, oxygen desaturation, or difficulty performing SLV. In this clinical situations, verification of tube position using fibreoptic bronchoscopy is indicated. Fibreoptic bronchoscopy requires rigorous training and practice to maintain a high level of skill as well as expensive infrastructure.
The VivaSight-DL (ETView Ltd, M.P. Misgav 20174, Israel) is a new DLT promising to exceed clinical performance of the conventional DLT. The VivaSight-DL is basically a left-sided DLT with an embedded video imaging device and light source at its tip and integrated cable with connector. However, after correct tube placement, the video imaging device is focused on the main carina, indicating the correct position of the bronchial cuff in the left main bronchus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET View Double Lumen Tube | Active Comparator | Patients assigned to the thisgroup will be intubated using the VivaSight-DL. |
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| conventional Double Lumen Tube | Active Comparator | Patients assigned to the first group will be intubated using conventional DLT (Bronchocath, left sided; RĂ¼sch, Kernen, Germany). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET View Double Lumen Tube | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| time to intubation | Time for intubation, defined as "time from insertion of the laryngoscope until statement of the intubating anesthesiologist, that DLT was correctly placed". Time for intubation will be measured by an independent researcher using a stop watch. | 300 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of misplacement | Rate of misplacement, occurring after patients removal from dorsal to lateral position | 3 hours |
| Rate of misplacement | Rate of misplacement, occurring during surgery, potentially caused by vibrations and movements by surgeons |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Beck Schimmer, Prof MD | University Hospital Zurich, Division of Anaesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Anaesthesiology | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25663254 | Derived | Schuepbach R, Grande B, Camen G, Schmidt AR, Fischer H, Sessler DI, Seifert B, Spahn DR, Ruetzler K. Intubation with VivaSight or conventional left-sided double-lumen tubes: a randomized trial. Can J Anaesth. 2015 Jul;62(7):762-9. doi: 10.1007/s12630-015-0329-8. Epub 2015 Feb 6. |
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| conventional Double Lumen Tube | Device |
|
|
| 3 hours |
| Rate of blind insertion | Rate of blind insertion, defined as successful placement of airway device in correct position in trachea/ main stream bronchus without help of fibreoptic bronchoscopy8 | 300 seconds |
| rate of fibreoptic bronchoscopy | Necessity of tube re-placement by fibreoptic bronchoscopy | 3 hours |
| Quality of lung collapse | 3 hours |
| Airway injuries | 3 hours |
| Postoperative coughing | 24 hours |
| Postoperative hoarseness | 24 hours |
| Postoperative sore throat | 24 hours |