COPD Breathing Record Study

• Research type

  Research Study

• Full title

  An exploratory, observational clinical evaluation of the CRiL N-Tidal C data-collector capnometer to collect breathing records in patients with COPD

• IRAS ID

  184530

• Contact name

  Ravi Mahadeva

• Contact email

  ravi.mahadeva@addenbrookes.nhs.uk

• Sponsor organisation

  Cambridge Respiratory Innovations Ltd.

• Duration of Study in the UK

  0 years, 3 months, 12 days

• Research summary

  A COPD Breathing Record Study : Capnometry Measurements of exhaled Carbon Dioxide in patients with COPD

  This trial will use a novel mainstream capnometer (the N-Tidal C data collector capnometer) to measure changes in exhaled carbon dioxide (CO2) of patients with chronic obstructive pulmonary disease (COPD). Patients will be enrolled into one of two cohorts: stable patients with chronic hypercapnia (raised blood levels of CO2) will be monitored in the community; hospitalised patients admitted with COPD-related respiratory failure will be monitored during recovery in hospital and post-discharge. Changes in exhaled CO2 profiles obtained by capnometry will be correlated with conventional markers of disease (arterial and capillary blood gas results) and clinical symptoms, which are currently routinely collected. Results from mathematical analysis of the research data collected in this study will be used to identify COPD-specific capnometry signatures. This information will ultimately facilitate the development of personalised point-of-care capnometers which will improve patient ownership of COPD through earlier recognition and treatment of exacerbations.
  This is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the N-Tidal C data-collector capnometer. Thirty patients with COPD will collect exhaled profiles of CO2 by normal tidal breathing through the N-Tidal C capnometer. The reading, which typically takes 60 seconds to collect, will be repeated three times daily, for a period of six weeks. Patients participating in the study will be recruited from the well-controlled COPD cohort of the respiratory team at Addenbrookes Hospital. The trial is funded from a development contract awarded by the Health Enterprise England Small Business Research Initiative (SBRI) program to Cambridge Respiratory Innovations Limited (CRiL) www.criltd.co.uk

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  15/YH/0369

• Date of REC Opinion

  10 Sep 2015

• REC opinion

  Further Information Favourable Opinion