Validation Of Tidal/End -Tidal CO2 in ALS

Launched by PAPWORTH HOSPITAL NHS FOUNDATION TRUST · Nov 30, 2018

Keywords

ClinConnect Summary

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 care. Researchers will ask permission to review the results of any medical investigations and tests previously undertaken, by looking in medical records and will collect new data prospectively. There will be two groups of patients recruited:

A).Hospital Questionnaire Monitoring Group (12 months) for up to 200 patients who will:

i) Have four routine hospital based assessments (every 3 months,...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 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 Criteria:
• • 1. 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.
• • 2. 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:
• • 1. Not in ventilatory failure at the start of the study (PaCO2 \< 6.0 KPa)
• • 2. 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).
• • 3. Verified able to use the device (by trial with dummy device).
• • 4. Stated intention at the start of the study that they will accept NIV if they develop ventilatory failure.
• • Home Monitoring Exclusion Criteria
• • 1. In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently.
• • 2. Established on NIV treatment