Pulmonary Disease, Chronic Obstructive Clinical Trial
— CBRSOfficial title:
An Exploratory, Observational Clinical Evaluation of TidalSense's N-Tidal C Data-collector Capnometer to Collect Breathing Records in Patients With COPD
Verified date | May 2023 |
Source | TidalSense |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2016 |
Est. primary completion date | July 6, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | Inclusion Criteria: - Patients aged 18 years and over. - Diagnosed with moderate to severe COPD. - Patients in the case managed group will have chronically elevated partial pressure of carbon dioxide (PaCO2) and be susceptible to frequent exacerbations of COPD. - Patients in the acute admission group will have been admitted to hospital via the emergency room for treatment of COPD-related ventilatory failure . Exclusion Criteria: - Diagnosis of neuromuscular disorder. - Diagnosis of Kyphoscoliosis. - Patients who, in the opinion of the investigator, are unlikely to comply with the requirements of the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrooke's Hospital | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
TidalSense | Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To assess the ability of patients with COPD to use the N-Tidal C data-collector capnometer daily and to capture user feedback. | 12-18 months | ||
Other | To assess the frequency of replacement of the consumable mouthpieces and batteries in normal daily use. | 12-18 months | ||
Primary | To collect a longitudinal observational study database of capnograph records for up to 30 patients with COPD using the N-Tidal C data-collector capnometer. | 4 months | ||
Secondary | To identify the correlation of carbon dioxide (CO2) measurements by capnography with those obtained by periodic standard arterial and capillary blood gas measurements. | 12-18 months | ||
Secondary | To identify the within-day and day-to-day variability of exhaled carbon dioxide in patients with COPD. | 12-18 months | ||
Secondary | To measure the absolute change in exhaled carbon dioxide measurements of patients admitted with an acute exacerbation of COPD during their recovery. | 12-18 months | ||
Secondary | To capture the carbon dioxide signature predictive of exacerbation in monitored patients who undergo an acute admission during the study. | 12-18 months |
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