Condition category
Surgery
Date applied
03/03/2013
Date assigned
10/06/2013
Last edited
24/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The majority of the chest surgeries, at Guy’s 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 Guy’s 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

Contact information

Type

Scientific

Primary contact

Dr Cheng Ong

ORCID ID

Contact details

Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

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 measures

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

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

http://www.guysandstthomas.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/06/2016: No publications found, verifying study status with principal investigator.