Warwick Spinal Immobiliser

ISRCTN	ISRCTN55006384
DOI	https://doi.org/10.1186/ISRCTN55006384
Secondary identifying numbers	12376

Submission date: 20/09/2012
Registration date: 04/12/2012
Last edited: 04/06/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rose Jarvis
Scientific

University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Email	rose.jarvis@warwick.ac.uk

Study information

Study design	Non-randomised observational qualitative study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Warwick Spinal Immobiliser - development and initial trial of prototype spinal immobilisation device
Study objectives	Traumatic spinal cord injury (SCI) is rare but has devastating consequences on the quality of life of patients and their families. Figures from the UK are difficult to obtain, but we estimate that 100,000 patients in England receive spinal immobilisation each year. As modern trauma care appropriately assumes that injury is present until excluded, this creates a huge demand for effective spinal immobilisation. Current methods usually involve a semi-rigid collar with head blocks and tape, but we and others have shown that this does not adequately immobilise the neck, allowing movement of the spine risking further injury. The rigid collar prevents opening of the mouth leading to feelings of claustrophobia, and potential danger of inhaling vomit. If the patient stops breathing, the collar must be removed to enable insertion of a breathing tube, increasing the risk of spinal cord damage. Pressure of the collar on the back of the head can cause pressure sores, and on the root of the neck can increase pressure within the brain, worsening any existing head injury. We have invented a device providing better immobilisation without preventing mouth opening, leading to a safer experience. It can be applied before the patient is removed from a vehicle increasing safety for patient and paramedic, and can be left on during X-rays and other investigations. We will train paramedics to use the device and ask volunteers to compare it to current methods by measuring movement of the spine, ability to open the mouth for normal breathing, ability to intubate, measuring risk of pressure sores, and conducting interviews and observations to gather the experience of volunteers and paramedics. Following feedback we will redesign and retest the device, and perform MR scanning that uses magnetic fields and a computer to measure movement between individual neck bones. We believe we have a device that is effective, more comfortable and safer for patients and easier for paramedics to use.
Ethics approval(s)	West Midlands - South, 31/05/2012, ref: 12/WM0098
Health condition(s) or problem(s) studied	Injuries and Emergencies, Anaesthetics
Intervention	We are testing two versions of the prototype device on healthy volunteers to measure the degree of immobilisation of the head in relation to the shoulders, and the spinal cord, compared to two currently-used devices. We are obtaining the opinions of paramedics trained to apply the device on how it can be improved, and how it compares to their normal experience of applying spinal immobilisation. We are obtaining the opinion of anaesthetists on ease of intubation of a manikin wearing the new and comparator devices.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Prototype testing
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/07/2012
Completion date	31/05/2013

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 140
Key inclusion criteria	1. Healthy volunteers employed by the ambulance service or medical school, or training as a medical student and a willingness to take part in the study 2. Male and female participants 3. Aged 18 - 60 years
Key exclusion criteria	1. For the first prototype testing we shall exclude people who have known neck problem or history of neck surgery, injury to the neck within the previous 12 months 2. Any condition resulting in restriction of neck movement, known claustrophobia, and, for the second prototype testing involving MR scanning 3. People with metallic implants, pacemaker 4. People who are, or may be, pregnant 5. Refusal to sign the confidentiality agreement will be an exclusion criterion
Date of first enrolment	01/07/2012
Date of final enrolment	31/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Warwick

Coventry
CV4 7AL
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom

Website	http://www2.warwick.ac.uk/
"ROR"	https://ror.org/01a77tt86

Funders

Funder type

Government

NIHR - Invention for Innovation (UK)

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

Editorial Notes

04/06/2018: No publications found, verifying study status with principal investigator.
03/05/2016: No publications found, verifying study status with principal investigator