Performance and Safety of an Airway Management Device Clinical Trial
Official title:
A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.
Single lung ventilation is frequently carried out to facilitate surgery on the lungs and
pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube
and then selectively ventilating one lung or both. Precise positioning of these tubes is
essential for optimal performance. It has become the standard of care to perform
bronchoscopy to confirm tube position.
A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all
the features of a standard double lumen endotracheal tube but also incorporates an internal
camera which, when connected to an external screen, allows continuous confirmation of tube
position.
This is randomized, single blinded controlled trial. The participants will be allocated to
two study groups (Vivasight DL or standard DLT), in which the primary airway management
device will be respectively Vivasight DL double lumen tube or a standard double lumen
endotracheal tube.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be
recruited after written informed consent.
Standard anesthetic preassessment and anesthesia will be provided.
Consenting patients passing the inclusion and exclusion criteria will be randomly allocated
to either of the 2 study groups.
Protocol for attempts at placement and tube position confirmation will be followed.
The investigators will monitor a number of parameters, including time and ease of tube
insertion, ability to verify tube position with the primary imaging modality for each group,
need to perform tube position adjustment maneuvers, need to use fiberoptic bronchoscope
during the case, quality of lung collapse, problems with ventilation and other.
The primary hypothesis is that the new Vivasight DL tube system will provide a comparable
optical view to the fiberoptic scope view obtained via standard double lumen endotracheal
tube in order to confirm optimal position.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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