Plain English Summary
Background and study aims
The majority of the chest surgeries, at Guys Hospital tertiary referral centre, require lung isolation. This is generally achieved by insertion of a breathing tube called a double lumen endotracheal tube (DLT). In order to confirm correct positioning of the DLT, it is recommended to use flexible fibreoptic bronchoscopes (tubes inserted to see the inside of the lung). These tubes have to be cleaned and disinfected after each use. They are also fragile and are prone to damage particularly during passage within the double lumen tube.
VivaSight™-DL (ETView Medical Ltd) double lumen tubes are manufactured as single use double lumen tubes with an integrated high resolution camera which provides real time images. The aim of this is to reduce the need for bronchoscopy (a procedure to see the airways) to confirm correct tube positioning and to enhance early recognition of tube displacement. This study aims to assess how well VivaSight DLT works.
Who can participate?
Adult female patients (age 18 years or over), due to undergo chest surgery requiring lung isolation, can participate in this study.
What does the study involve?
The patient will be given a general anaesthetic and a muscle relaxant. The VivaSight DLT will then be inserted into the patient. The time taken to insert the tube and to isolate the lung will be studied. We will also be looking for any incidental airway defects.
What are the possible benefits and risks of participating?
The VivaSight DLT is virtually identical to the standard DLT used at Guys Hospital and will be inserted by an experienced consultant. The benefits of this study will be for future patients, to enable continuous viewing of the airway and enhance placement of the tube. It is possible that using the VivaSight tube may cause sore throat, hoarseness, swallowing difficulties, coughing, difficulty breathing and damage to teeth. An uncommon side effect can be damage to the windpipe. All of these side effects, however, can occur after any general anesthetic for chest surgery.
Where is the study run from?
The study will be run at Guys Hospital in the thoracic theatres.
When is the study starting and long is it expected to run for?
The study starts in June 2013 and is expected to run for 3 months.
Who is funding the study?
The VivaSight DLTs are being provided by the manufacturing company free of charge.
Who is the main contact?
Dr Cheng Ong, cheng.ong@gstt.nhs.uk
Dr Caroline Dean, cally_dean@hotmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Case series: Double-lumen tracheal intubation using VivaSight DLT
Acronym
Study hypothesis
Case series to assess and quantify the timing required to isolate lungs, and the ease of intubation, using the VivaSight™ double lumen tube (DLT).
Ethics approval
Proportionate Review Sub-Committeee, 25/03/2013, ref: 13/NW/0204.
Study design
Observational case series
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Female patients undergoing thoracic surgery requiring lung isolation
Intervention
The use of the VivaSight DLT, which will be inserted once the patient is under a general anaesthetic and has been administered a muscle relaxant.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
1. Quantify time to successful intubation and separation of lungs using VivaSight™-DL
2. Quantify failure or number of attempts until successful lung separation
3. Quantify complications
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/05/2013
Overall trial end date
01/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients, age 18-99 years
2. Thoracic surgery requiring left sided 37 fr Double lumen tube
3. American Society of Anaestesiologists (ASA) categories 1-3
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
8
Participant exclusion criteria
1. Age less than 18 years
2. ASA category 4
3. Known or predicted difficult airway
4. Require rapid sequence induction or another anaesthetic technique deviating from that outlined in the protocol
Recruitment start date
01/05/2013
Recruitment end date
01/07/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guys Hospital
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' Foundation NHS Trust (UK)
Sponsor details
c/o Ms Karen Ignatian
R&D Department
16th Floor Tower Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
VivaSight DLT will be provided by the manufacturing company ETView Medical Ltd. free of charge. No further funding is required for this case series.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26535556 (added 21/01/2019)