The General Breathing Record Study

Study Overview
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Brief Summary
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This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.

Detailed Description
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When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or waveform. This waveform can tell a clinician a lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform. This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.

Official Title
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An Observational Proof-of-concept Study to Explore the Waveform Characteristics of Tidal Breathing Carbon Dioxide (CO2), Measured Using the N-Tidal C™ Device, in Different Breathing Conditions.

Conditions
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Asthma, Heart Failure, Pneumonia, Motor Neuron Disease, Vocal Cord Dysfunction, Breathlessness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma Cohort: A confirmed clinical diagnosis of asthma for ≥ 6months Moderate to severe asthma defined as British Thoracic Society stages 3-5 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months. Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics). Breathing Pattern Disorder Cohort A Clinical diagnosis of a Breathing Pattern Disorder (BPD) Chronic heart failure Cohort: A confirmed clinical diagnosis of chronic heart failure with both of the following: A Left Ventricular Ejection Fraction <40% on most recent imaging within the last 12 months. New York Heart Association Class 2-4 Admitted with an acute decompensation of their heart failure to hospital within the last 6 months Motor Neurone Disease Cohort: A confirmed clinical diagnosis of Motor Neurone Disease Forced Vital Capacity (FVC) of less than 60% of predicted, sleep disordered breathing or daytime hypercapnia. Established on Home Non-Invasive Ventilation. Pneumonia Cohort: A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging. Healthy Cohort: No known history of lung, cardiac or neuromuscular disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung, cardiac or neuromuscular disease). A Body Mass Index of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history. Exclusion Criteria: Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or Tidal Breath Carbon Dioxide measurements. In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma<br>20 Participants with moderate to severe asthma, as defined by British Thoracic Society (BTS) guidelines | |
| Chronic heart failure<br>10 Participants with a diagnosis of chronic heart failure | |
| Breathing Pattern Disorder<br>10 Participants with a diagnosis of Breathing Pattern Disorder | |
| Pneumonia<br>10 participants with a radiologically confirmed diagnosis of pneumonia | |
| Motor Neurone Disease<br>10 participants with a diagnosis of motor neurone disease with known hypercapnic failure. | |
| Healthy<br>10 Participants who have no known lung, cardiac or neuromuscular condition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Tidal Breathing carbon dioxide waveform over time | Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months. | Change measures - baseline to 6 months | 
| Disease Control in asthma patients | The Asthma Control Questionnaire Score for the Asthma patients | 12 months | 
| Disease Improvement in Breathing Pattern Disorder patients | The Nijmegen Questionnaire Score | 12 months | 
| Disease severity in the pneumonia patients | The CURB-65 Score | 2 days | 
| Disease severity in heart failure patients | The Trans Thoracic Echocardiogram (TTE) result | 12 months | 
| Hypercapnia in the motor neurone disease patients | The level of partial pressure carbon dioxide (pCO2) | 12 months | 
| Usability of the N-Tidal C device | Measured by how frequently the patients remember to use the N-Tidal C device over 6 months | Change measures - baseline to 6 months | 
| Acceptability of the N-Tidal C device | Measured by a questionnaire of the participants experience of the device at the end of the study | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capnography, Diagnosis. Breathlessness, Exacerbations, Device