Funded by National Institute for Health Research Invention for Innovation programme

Phase one is now complete and we are now planning phase 2 which consists of redesign on one component and then retesting.

Background

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. We will also 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.

Aim

To develop a new form of spinal immobilisation that improves on current design.

The trial

We have developed a prototype device that we will test using volunteers, and compare with the current gold standard forms of spinal immoiblisation.

The primary endpoint is the mean movement of the cervical spine, measured in degrees.

Secondary endpoints are quantitative measurement of tissue-interface pressure, amount of mouth opening possible with the device in place measured as a percentage of that possible with no device in place, quantitative measures of volunteer experience, quantitative and qualitative paramedic opinion of ease of use, and quantitative and qualitative anaesthetist opinion on ease of intubation of a manikin whilst devices are applied.

As this device is not yet on the market, the design is confidential. For this reason, we shall require all volunteers to sign a clause within the consent form agreeing to maintain confidentiality of all details of the device for a period of seven years.

If you would lilke further information at any time, please email spine at warwick dot ac dot uk

Phase one

This phase of the trial has completed recruiting

You will find further information that we used in phase one for healthy volunteers on this page, for paramedics/technicians/medical students on this page, and anaesthetists on this page. We would like to find some volunteers who have previous experience of spinal immobilisation, and the information for them may be found on this page.

The regulatory details of Phase one

NIHR Portfolio number: 12376

Research Ethics Committee favourable opinion granted on 31st May 2012, reference number 12/WM/0098

MHRA reference number CI/2013/0011

ISRCTN55006384

Interested in participating in Phase two?

We are currently applying for ethics approval and will then be looking for some healthy volunteers. We will ask volunteers to assist us to compare ithe modified device to cone other device by measuring movement of the spine, the ability to open the mouth, measuring risk of pressure sores, and conducting interviews on comfort.

Further information will be available soon.

If you are interested in particpating then please contact us by laura dot j dot vail at warwick dot ac dot uk