Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study
Research type
Research Study
Full title
A Feasibility Study Monitoring the Respiratory Status of Participants Receiving or Scheduled to Receive Intrathecal Baclofen (ITB)
IRAS ID
208374
Contact name
Hayden Kirk
Contact email
Sponsor organisation
Solent NHS Trust
Duration of Study in the UK
0 years, 4 months, 11 days
Research summary
There are currently 10 million people in the UK diagnosed with a neurological condition and account for 700,000 emergency admissions in 2012/2013. People with a neurological condition are at higher risk of respiratory compromise and consequently are vulnerable to respiratory infection. Over 50% of patients with acquired brain injuries or degenerative neurological conditions will also experience muscle spasticity and spasms. Traditional management of spasticity involves pharmacological and postural control. Common first line medicines to help manage global spastic muscles are oral drugs such as baclofen, tizanidine and gabapentin. Unfortunately many patients taking such medications experience debilitating side effects such as drowsiness, and are often unable to tolerate sufficient levels of the medication to control their spasticity and spasms. Surgical procedures have been developed which can directly administer baclofen into the lower spinal cord via a catheter from a pump placed in the abdomen; this is known as Intrathecal Baclofen therapy (ITB). This is a relatively new and specialist procedure and there is conflicting evidence relating to the influence of ITB on a person’s central respiratory drive and peripheral muscles of breathing. There is therefore an important need to establish the effect that ITB may have on the respiratory system of vulnerable neurological patients with equipment that is practical and acceptable for patients residing in the community. This feasibility study will recruit adult patients receiving or scheduled to receive ITB from Solent NHS trust Intrathecal Baclofen Service at the Western Community Hospital. The participants will have their respiratory status evaluated via effort dependent measures and a home sleep study over two consecutive nights. Participants and their carers will also be asked for feedback on the acceptability and experience of undertaking these measures. The study will run between January and May 2017.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0649
Date of REC Opinion
24 Jan 2017
REC opinion
Further Information Favourable Opinion