Case series to evaluate the use of the VivaSight double lumen tube

ISRCTN	ISRCTN85628303
DOI	https://doi.org/10.1186/ISRCTN85628303
Secondary identifying numbers	1

Submission date: 03/03/2013
Registration date: 10/06/2013
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Cheng Ong
Scientific

Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Study information

Study design	Observational case series
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Case series: Double-lumen tracheal intubation using VivaSight DLT
Study objectives	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(s)	Proportionate Review Sub-Committeee, 25/03/2013, ref: 13/NW/0204.
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2013
Completion date	01/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Female
Target number of participants	8
Key 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
Key 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
Date of first enrolment	01/05/2013
Date of final enrolment	01/07/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guys Hospital

London
SE1 9RT
United Kingdom

Sponsor information

Guy's and St Thomas' Foundation NHS Trust (UK)
Hospital/treatment centre

c/o Ms Karen Ignatian
R&D Department
16th Floor Tower Wing
Great Maze Pond
London
SE1 9RT
England
United Kingdom

Website	http://www.guysandstthomas.nhs.uk
"ROR"	https://ror.org/00j161312

Funders

Funder type

Industry

VivaSight DLT will be provided by the manufacturing company ETView Medical Ltd. free of charge. No further funding is required for this case series.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2016	21/01/2019	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

21/01/2019: Publication reference added
24/06/2016: No publications found, verifying study status with principal investigator.