Chronic Obstructive Pulmonary Disease (COPD) Breathing Record Study
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This study is being done to collect information that will be used in the development of a new
      medical device. The new device is intended to help people with COPD to monitor their
      condition at home on a daily basis.

      The device used in this study is called a capnometer. Different types of capnometer have been
      in use by doctors for many years. Capnometers measure the amount of carbon dioxide in your
      breath. The device that is used in this study is called the N Tidal C. It is a small,
      battery-powered personal device for you to use indoors either at home, at work or in
      hospital.

      The study fits around the normal treatment, tests and medication of COPD patients and there
      will not be any changes made to the treatment of any study participants.

      The study lasts for six weeks. Standard care clinical assessments will be taken at the start
      of the study, after 2 weeks, 4 weeks and 6 weeks. The tests for COPD include a check-up by
      the study doctor or nurse including the usual spirometry and blood gas tests. Each assessment
      visit will last for between 15-20 minutes.

      At the start of the study each participant will be trained in the use of the device and they
      will be asked to use the device to record their normal relaxed breathing, 3 times a day
      (morning, afternoon and evening) every day for the 6- week period. A reading takes
      seventy-five seconds of ordinary breathing through the device.

      Participants who feel unwell, or have an infection, will be asked to take more frequent
      breath records of up to six times a day if possible. This would be twice in the morning,
      twice in the afternoon and twice in the evening, leaving at least an hour between readings.

      Participants will also be asked to complete a simple daily diary of how their health and COPD
      changes and information on the use of the device.

      Participants will receive a telephone call 2 weeks after their last assessment visit to check
      how they are and to ask if any of their medicines have changed.

      Participants will not benefit directly from taking part in this study and the device used in
      the study does not provide any feedback to them. The information we get from this study will
      help us to develop the device, and to learn more about the treatment and management of COPD.
    

Detailed description: 
      Study design: This is an uncontrolled, non-randomised, un-blinded longitudinal observational
      data collection study with the N-Tidal C data-collector capnometer in patients with COPD.
      Patients will be enrolled into one of two cohorts: community-based case managed patients with
      chronic hypercapnia, and hospitalised patients who have been admitted via the emergency room
      for the treatment of COPD-related ventilatory failure.

      Patients who give informed consent will be screened for the study. Patients in the
      case-managed group will be screened at home or in routine clinic visits. Patients in the
      acute admission group will be screened after admission to hospital as soon as they are well
      enough to understand the study and to give written informed consent.

      The N-Tidal C data-collector capnometer will be explained to the patients and they will be
      trained how to use it. Case-managed patients will be asked to use the device at home over a
      period of approximately 6 weeks, 3 times per day (morning, afternoon and evening), or 6 times
      per day if they feel that they are starting an infection or an exacerbation. Hospitalised
      patients will also use the device 3 times per day as in-patients and will then continue with
      the monitoring after discharge from hospital for a total period of 6 weeks. All patients will
      complete a daily diary record.

      Case-managed patients will undergo clinical assessment of COPD during screening at home or in
      the COPD clinic; in-patients will undergo clinical assessment of COPD following admission and
      before discharge from hospital. All patients will be assessed a further 3 times: during the
      second and fourth week in the community, and at the end of the 6-week assessment period. A
      brief follow-up review will be conducted approximately 8 weeks after the start of capnometer
      monitoring. At each assessment, capnometry measurements will be taken in addition to routine
      spirometry, and arterial (in-patients) or capillary (in the community) blood gasses. The
      trial will not interfere with routine management of the patient's condition.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 30 men and women with a diagnosis of moderate to severe COPD.