Chronic Obstructive Pulmonary Disease (COPD) Breathing Record Study

NCT02814253 | Completed

• 1 other identifier: G001-15_CBRS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• To identify the within-day and day-to-day variability of exhaled carbon dioxide in patients with COPD.

  12-18 months

• 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

• To capture the carbon dioxide signature predictive of exacerbation in monitored patients who undergo an acute admission during the study.

  12-18 months

Other Outcomes (2)

• 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

• To assess the frequency of replacement of the consumable mouthpieces and batteries in normal daily use.

  12-18 months

Study Arms (2)

Community Based Group

Patients who regularly present with exacerbations of COPD and have chronically-elevated CO2 levels. These patients are supported intensively in an out-patient setting (case-managed) and are potentially eligible for the community-based group.

Acute Admissions Group

Patients who are admitted to hospital with an acute exacerbation of COPD. These patients are potentially eligible for the acute admission group.

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 30 men and women with a diagnosis of moderate to severe COPD.

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• TidalSense: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB24 5AA, United Kingdom

Location

Related Publications (1)

• Talker L, Neville D, Wiffen L, Selim AB, Haines M, Carter JC, Broomfield H, Lim RH, Lambert G; BRS Study Team; Weiss ST, Hayward G, Brown T, Chauhan A, Patel AX. Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer. Respir Res. 2023 Jun 2;24(1):150. doi: 10.1186/s12931-023-02460-z.

  PMID: 37268935 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ravi Mahadeva

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: February 17, 2016
• Primary Completion: July 6, 2016
• Study Completion: December 1, 2016
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

GB (1)