NCT Number: NCT03665896
VivaSight Left-sided Double Lumen Tube Study
The VivaSight™-DLT is a new OLV (one lung ventilation) device that contains an embedded camera. Therefore, a potential advantage is the continuous assessment of DLT position through continuous monitoring of the camera. The embedded camera of VivaSight™-DLT is positioned at the tracheal opening of the double lumen tube. It allows for continuous monitoring of the carina and bronchial tube placement.
The purpose of this study is to determine if a double lumen tube (DLT) with an embedded video camera, the VivaSight DLT, can be used in similar fashion to the standard double lumen tube with fiberoptic bronchoscopy. More specifically, the investigators would like to know the difference in time to optimal position in the left bronchus between the VivaSight DLT and the standard DLT with fiberoptic bronchoscopy. In addition, the investigators would like to know if the embedded camera on the VivaSight DLT provides a view that will allow for the optimum position of the DLT in the left bronchus.
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Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
The investigators will perform a prospective, randomized study in thoracic surgical patients undergoing one-lung ventilation where the patient will receive either the VivaSight DLT or standard left-sided DLT. Subjects will be selected and evaluated who are at least 18 years old, but no older than 90 years old.
The investigators will compare the intubation time for the VivaSight™-DLT with the intubation time for standard DLT. The intubation time parameters for the VivaSight™-DLT are the passage of the tube through the vocal cords and the confirmation of proper tube positioning by the embedded camera. Fiberoptic bronchoscopy is performed to reassess the proper tube positioning, however, this will not be counted for the intubation time in this group. For the standard DLT, the intubation time parameter begins similarly, on the passage of the tube through the vocal cords, but ends with the confirmation of the proper placement by fiberoptic bronchoscopy. In both groups, C-MAC blade is used to visualize the passage of the tube through the vocal cords. These intubation times will be tracked real-time in the operating room and will be based upon both observation as well as the verbal confirmation of the attending anesthesiologist.
The intubation time must be within 5 minutes. The intubation time required more than 5 minutes is considered as unsuccessful intubation.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- At least 18 years of age
- Adult patient undergoing scheduled thoracic surgery which requires double-lumen tube placement
Exclusion criteria
- More than 90 years of age
- Patients with emergency surgery
- Prisoners
- Patient who cannot provide their own consent
- Patient refusal
- Non-English speaking patients
Treatment and study plan
intubation with standard double-lumen tube
Devicefiberoptic bronchoscopy
ProcedurePrimary outcomes
-
Intubation time
Time frame: Within 5 minutes
We will compare the intubation time for the VivaSight double-lumen tube (DLT) with the intubation time for standard DLT.
Secondary outcomes
-
Picture reliability of the embedded camera of VivaSight double-lumen tube
Time frame: Within 10 hours
Picture reliability of the embedded camera will be assessed based upon the proper identification of the following structures; a) Carina, b) Left bronchial cuff , c) A radiopaque line of left bronchial tube, d) Right main bronchus.
Sponsors and collaborators
Lead sponsor
Javier H Campos
Other
Registry information
Official study title
A Comparison of Placement With the VivaSight Left-sided Double Lumen Tube With an Integrated Monitor/Camera Versus the Standard Left-sided Double Lumen Tube (DLT) With Fiberoptic Bronchoscopy in Patients Requiring One-lung Ventilation (OLV)
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 11, 2018
- Registry last updated
- Sep 11, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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