Patients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During Surgery Clinical Trial
Official title:
Prospective, Randomized Clinical Trial Evaluating the ETView Double-Lumen Tube
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.
- Trial with medical device
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment