Status:
UNKNOWN
Validation Of Tidal/End -Tidal CO2 in ALS
Lead Sponsor:
Papworth Hospital NHS Foundation Trust
Collaborating Sponsors:
Motor Neurone Disease Association
Innovate UK
Conditions:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
The study team propose that a new, hand-held test device may be valuable in the management of breathing failure in patients with Motor Neurone Disease (MND). The study team need to validate this devic...
Detailed Description
This is a prospective, observational study of patients attending Royal Papworth Hospital's weekly MND clinic. If a patient decides to participate in the study, they will continue to receive all normal...
Eligibility Criteria
Inclusion
- \- 1. Male or female with a diagnosis of definite or probable Motor Neurone Disease according to El Escorial criteria.
- 2\. Willing and able to provide informed consent.
Exclusion
- Lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would markedly affect spirometry and/or other measures of lung function or TBCO2 measurements. To be judged by the CI.
- Tracheostomy in situ
- Additional Eligibility Criteria for Home Monitoring patients Patients invited to use the N-Tidal CTM data collecting device within the study would be selected using the following additional inclusion criteria. These patients in theory would be most likely to get reliable results from the capnometer, be candidates for NIV, and to reach one of the study end-points within the follow-up period.
- Home monitoring Inclusion Criteria:
- Not in ventilatory failure at the start of the study (PaCO2 \< 6.0 KPa)
- Sufficient manual dexterity and arm strength to use the device (or have a live-in carer/spouse/family member able to assist and willing to do so).
- Verified able to use the device (by trial with dummy device).
- Stated intention at the start of the study that they will accept NIV if they develop ventilatory failure.
- Home Monitoring Exclusion Criteria
- In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently.
- Established on NIV treatment
Key Trial Info
Start Date :
August 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 4 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03764384
Start Date
August 20 2018
End Date
June 4 2021
Last Update
March 10 2021
Active Locations (1)
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1
Royal Papworth NHS Foundation Trust
Papworth Everard, Cambridge, United Kingdom, CB23 3RE