Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name used to refer to a number of progressive devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. There is no cure for the condition, but making lifestyle changes (such as stopping smoking) and taking medications (inhalers and/or tablets) can alleviate symptoms. 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 chronic obstructive pulmonary disease (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 the breath. The device that is used in this study is called the N-Tidal C. It is a small, battery-powered personal device to use indoors either at home, at work or in hospital.
Who can participate?
COPD patients aged at least 18
What does the study involve?
The study fits around the a COPD patient’s normal treatment, tests and medication and there are no changes made to this treatment. At the start of the study each participant is trained in the use of the device and they are asked to use the device to record their normal relaxed breathing, 3 times a day (morning, afternoon and evening) every day for the next six weeks. A reading takes 75 seconds of ordinary breathing through the device. Participants who feel unwell, or have an infection, are asked to take more frequent breath records of up to six times a day if possible – that is twice in the morning, twice in the afternoon and twice in the evening - leaving at least an hour between readings. Standard care clinical assessments are taken at the start of the study, after 2 weeks, 4 weeks and, finally, 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 takes between 15-20 minutes. Participants are also asked to complete a simple daily diary of how their health and COPD changes and information on the use of the device. Finally, all participants 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.
What are the possible benefits and risks of participating?
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 the researchers get from this study will help them to develop the device, and to learn more about the treatment and management of COPD. The study researchers do not believe that there are any risks to participants who use the N-Tidal C device in accordance with the instructions for use. An early version of it was tested on people with COPD and they did not report any side effects or difficulties with breathing through the device.
Where is the study run from?
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Lung Function Unit (UK)
When is the study starting and how long is it expected to run for?
January 2016 to July 2016
Who is funding the study?
The Small Business Research Initiative for Healthcare (UK)
Who is the main contact?
Dr Ravi Mahadeva
Trial website
Contact information
Type
Public
Primary contact
Dr Ravi Mahadeva
ORCID ID
http://orcid.org/0000-0001-6111-5555
Contact details
Consultant Chest Physician
Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02814253
Protocol/serial number
19599
Study information
Scientific title
An exploratory, observational clinical evaluation of the CRiL N-Tidal C data-collector capnometer to collect breathing records in patients with COPD
Acronym
CBRS
Study hypothesis
The purpose of this planned investigation is to collect data from patients whose COPD is undergoing change. Such patients are either at risk of an acute exacerbation of COPD, or they have already been hospitalised for treatment of an acute exacerbation. The intention is to correlate capnometric data during this journey with existing measurements (spirometry, blood gas, partial pressure of carbon dioxide [PaCO2], clinical symptoms and clinical assessments). It should then be possible to predict the exhaled CO2 signature of an exacerbation of COPD in normocapnic and hypercapnic patients.
The eventual aim of the N-Tidal C is to facilitate the monitoring and management of patients in the community with moderate to severe COPD. In its final developed form, the N-Tidal C will detect any changes in the patient’s exhaled CO2 capnograph, which would indicate a worsening of their condition and risk of exacerbation. The device would then use a ‘traffic light’ warning system to advise the patient of a change of condition, prompting the patient to seek medical attention. This timely intervention in the community should reduce the number of COPD admissions to hospital.
Ethics approval
NRES Committee Yorkshire & The Humber - Bradford Leeds, 10/09/2015, ref: 15/YH/0369
Study design
Observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Specialty: Respiratory disorders, Primary sub-specialty: COPD
Intervention
Patients will be enrolled into one of two cohorts:
1. Stable patients with chronic hypercapnia (raised blood levels of CO2). They will be monitored in the community (community-based case managed group)
2. Hospitalised patients admitted with COPD related respiratory failure. They will be monitored during recovery in hospital and post discharge (acute admission group)
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.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Changes in exhaled CO2 profiles obtained by the N-Tidal C data-collector capnometer. The reading, which typically takes 60 seconds to collect, will be repeated three times daily, for a period of six weeks.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
07/01/2016
Overall trial end date
01/07/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients of either sex, age 18 years and over, diagnosed with COPD, who have given written, informed consent
2. Patients in the case-managed group will have chronically elevated partial pressure of
carbon dioxide (PaCO2) and will be susceptible to frequent exacerbations of COPD
3. Patients in the acute admission group will have been admitted to hospital via the emergency room for treatment of COPDrelated ventilatory failure
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Diagnosis of neuromuscular disorders or kyphoscoliosis
2. 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
Recruitment start date
17/02/2016
Recruitment end date
05/05/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Lung Function Unit, Box 40
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge Respiratory Innovations Ltd
Sponsor details
The Grange
20 Market Street
Swavesey
Cambridge
CB24 4QG
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
The Small Business Research Initiative for Healthcare (SBRI Healthcare)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The first publication from the study will be a poster at the 2017 European Respiratory Society conference. Further publications are planned in high impact peer-reviewed journals.
IPD sharing statement
The datasets generated and/or analysed during the current study are not expected to be made publicly available due to commercial sensitivity with the development of N-Tidal technology and personal respiratory monitors.
Intention to publish date
01/08/2019
Participant level data
Not expected to be available
Basic results (scientific)
See additional file ISRCTN56492264_BasicResults_25July17.pdf
Publication list
Publication citations
Additional files
- ISRCTN56492264_BasicResults_25July17.pdf Uploaded 01/08/2017