Validation Of Tidal/End -Tidal CO2 in ALS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-20

Study Completion Date

2021-06-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Relationship Between Arterial Stiffness and Respiratory Failure in Motor Neurone Disease

NCT03444428

Motor Neurone Disease Hypoxemia and/or Hypercapnia

COMPLETED

Efficacy of Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)

NCT00537641

Amyotrophic Lateral Sclerosis Motor Neuron Disease

COMPLETED

Concordance Between ETCO2, PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient

NCT02068911

Neuromuscular Disease Chronic Respiratory Insufficiency Intermittent Positive-pressure Ventilation

COMPLETED

"New Perspectives of Adaptation to NIV in ALS"

NCT02537132

Amyotrophic Lateral Sclerosis (ALS)

COMPLETED NA

Home Versus Hospital Based NIV Care in MND

NCT06844370

Motor Neurone Disease Respiratory Insufficiency

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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, standard care) ii) Above usual care: completion of the ALSFRS-R questionnaire at each clinic (4 in total. The ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Score-Revised) measures range of difficulties that people with MND can have in their daily lives. The results from this questionnaire help to measure the severity of MND symptoms, and how fast the disease is progressing. B). Home Device Monitoring Group (12-24 months) for 30 patients These participants patient will be given a portable monitoring device (called the N-Tidal C) to record their breathing pattern in clinic and at home and have: i) Four to six routine hospital based assessments (every 3 months, standard care). At the discretion of the investigator this may be at each clinic visit up to a total of 24 months ii) Completion of an ALSFRS-R symptom questionnaire at each visit (4-6 in total). At the discretion of the investigator this may be at each clinic visit up to a total of 24 months iii) Telephone consultation 2 weeks after commencing home monitoring to validate correct and safe use of the device (1 in total) iv) Completion of a supervised N-Tidal C breath record at each clinic visit (4 to 6 total). At the discretion of the investigator this may be at each clinic visit up to a total of 24 months v) Completion of a weekly symptom diary (up to 52 in total). At the discretion of the investigator this may continue up to 24 months vi) Home monitoring with N-Tidal C for 75 seconds, up to 3 times per day (up to study finish). SA 02 introduced an additional modified breath holding manoeuvre for home monitoring patients in clinic.

The range of 4 to 6 assessments covers the eventuality that participants may start in group A and transfer to group B as their condition changes. This will be determined by the treating doctor and will be based upon their lung function, limb weakness and whether they (or a carer) are able to use the device. During the home monitoring trial, data collected by the N-Tidal C device will be downloaded at each clinic visit, to check that the device is correctly recording data. Researchers will not be able to analyse the data collected by the device.

Only the information obtained from the standard measurements (standard care) will be used to decide when a patient needs help with their breathing at night time by starting a ventilator. A patient participating in the Home Monitoring Group will continue to use their N-Tidal C device to record their daytime breathing up to 3 times per day, after they start using a ventilator.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Motor Neuron Disease Amyotrophic Lateral Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hospital Monitoring Group - ALSFRS-R cohort

All patients will be first recruited to this cohort unless at their first visit the investigator deems them eligible for the Home Monitoring Device Group. At the initial screening visit, all patients recruited into the study will undergo routine assessments according to the existing MND protocol, and additionally complete the ALSFRS-R symptom-based assessment questionnaire by interview with the study researchers (with assistance from spouse, family member or carer if required). Patients will continue to complete the ALSFRS-R symptom-based questionnaire at each clinic attendance.

No interventions assigned to this group

Home Monitoring Cohort

If eligible patients will use the N Tidal CTM, up to 3 times a day (morning, midday and evening) throughout the home monitoring period until the final outpatient clinic visit.

In addition subjects will complete a weekly diary symptom monitoring diary which asks them about their respiratory symptoms, GP attendances, respiratory infections. Patients routine standard of care assessments will also be documented according to the protocol as well as completing the ALSFRS-R at each visit.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

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

1. In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently.
2. Established on NIV treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No