COPD Breathing Record Study 2

Study Overview
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Brief Summary
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The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). The patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. The data will also be examined to assess the predictive possibility of a non-invasive self-care personal CO2 monitoring device to identify COPD exacerbations.

Detailed Description
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Study Design: This is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the N-Tidal C Data Collector Device in patients with COPD. Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Those patients who are classified as COPD with appropriate inclusion criteria (below) will be invited to participate. Patients who give informed consent will be screened for the study. The N-Tidal C Data Collector Device will be explained to the patients and they will be trained how to use it. All patients will complete a short daily diary record. Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. The study will not interfere with routine management of the patient's condition.

Official Title
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Characterisation of COPD Breathing Records During Exacerbations

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40 years and over. Diagnosis of COPD (Primary) and at least one moderate exacerbation within 12 months of the start of the study period. Able to provide signed informed consent. Exclusion Criteria: Patients who, in the opinion of the investigator, are unlikely to comply with the requirements of the study, use the device correctly or keep the diary records; Diagnosis of neuromuscular disorders or Kyphoscoliosis; Diagnosis of other Respiratory disorders that, in the opinion of the investigator, would impact the conduct of the study e.g. clinically significant bronchiectasis, asthma; Patients who have experienced an exacerbation of their COPD that has required treatment with antibiotics and/or oral corticosteroids within 2 weeks prior to the study start.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with moderate-to-severe COPD.<br>Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the changes in the α angle of the tidal breathing CO2 (TBCO2) waveform data from stable COPD through an exacerbation and back to stable. | The α angle is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. The α angle is given in degrees and significant changes in the α angle have previously been observed between stable COPD and acute exacerbations of COPD. | Throughout the 26 week use of the N-Tidal C device for each patient. | 
| To measure the minimum and maximum CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable. | The minimum and maximum CO2 levels are key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD. | Throughout the 26 week use of the N-Tidal C device for each patient. | 
| To measure the variability of breath length of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable. | The variability of breath length is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. Breath length is measured in seconds and significant differences have previously been observed between stable COPD and acute exacerbations of COPD. | Throughout the 26 week use of the N-Tidal C device for each patient. | 
| To measure the standard deviation of End Tidal CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable. | The standard deviation of End Tidal CO2 levels is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. End Tidal CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD. | Throughout the 26 week use of the N-Tidal C device for each patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal Database | To collect a longitudinal observational database of TBCO2 waveform records for up to 50 patients with COPD over a period of 26 weeks using the N-Tidal C device. | Throughout the 26 week use of the N-Tidal C device for each patient. | 
| COPD Exacerbations | To capture the carbon dioxide signature predictive of exacerbations in monitored patients who undergo mild, moderate and severe exacerbations during the study. | Throughout the 26 week use of the N-Tidal C device for each patient. | 
| COPD Variability | To identify the within-day and day-to-day variability of respired CO2 in patients with COPD | Throughout the 26 week use of the N-Tidal C device for each patient. | 
| Usability of the N-Tidal C device | Measured by the patients compliance and perseverance to the use the N-Tidal C device. | Throughout the 26 week use of the N-Tidal C device for each patient. | 
| Acceptability of the N-Tidal C device | The patients will be asked questions about the ease of use of the N-Tidal C and twice daily respiratory monitoring. | At the end of the 26 week use of the N-Tidal C device for each patient. | 

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