At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory, Observational Clinical Evaluation of TidalSense's N-Tidal C Data-collector Capnometer to Collect Breathing Records in Patients With COPD
In Brief
An observational study for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 30 participants across 1 site.
Detailed 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.