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Validation Of Tidal/End -Tidal CO2 in ALS

NCT03764384 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-03-10

No results posted yet for this study

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 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. The 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. The team 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 Papworth's clinic, recruited to this study, collected over a year the team 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.

Conditions

Sponsors & Collaborators

  • Motor Neurone Disease Association

    collaborator UNKNOWN

  • Innovate UK

    collaborator OTHER_GOV

  • DOCATEF

    collaborator UNKNOWN

  • TidalSense

    collaborator INDUSTRY

  • Papworth Hospital NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Ian E Smith, MA MD F.R.C.P · Royal Papworth NHS Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2021-06-04
Completion
2021-06-04

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764384 on ClinicalTrials.gov