Validation of Tidal/End-tidal CO2 in ALS (VOTECO2ALS)
Research type
Research Study
Full title
An observational study in people with Amyotrophic Lateral Sclerosis to validate Tidal/End Tidal CO2, measured by the N-Tidal C™ against directly measured PaCO2 and to determine the ease of home use of the device.
IRAS ID
239222
Contact name
Ian Smith
Contact email
Sponsor organisation
Royal Papworth Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
We propose that a new, hand-held test device may be valuable in the management of breathing failure in patients with Motor Neurone Disease (MND). We need to validate this device against the current gold standard of blood gas analysis and determine whether people with MND can use it at home. The new device, called ‘N-Tidal C™’ measures the carbon dioxide (CO2) in expired breath. At the end of the breath (end tidal) the CO2 level gives an indication of the CO2 in the person’s arterial blood. Ventilatory failure is diagnosed at present using the value of CO2 in the arterial blood, but usually this can only be measured in specialist clinics. \nOur study will determine if the end tidal CO2 measured by the new device agrees with CO2 measured on a blood test in clinic and also whether or not the device is practical for home use. We will analyse the output of the device during home monitoring to see if changes in the pattern of CO2 in the expired breath identify, or even predict, the development of breathing failure in the community. With the results of these measures and detailed information about the patients in our clinic, recruited to this study, collected over a year we will design a follow on study to see if using the new device at home can improve survival and quality of life for people with MND.\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0112
Date of REC Opinion
31 May 2018
REC opinion
Further Information Favourable Opinion