Pulmonary Disease, Chronic ObstructiveCBRSNCT02814253
Chronic Obstructive Pulmonary Disease (COPD) Breathing Record Study
An observational study of Pulmonary Disease, Chronic Obstructive, run by TidalSense at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 30 men and women with a diagnosis of moderate to severe COPD.
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB24 5AA
About this study
Official title: An Exploratory, Observational Clinical Evaluation of TidalSense's N-Tidal C Data-collector Capnometer to Collect Breathing Records in Patients With COPD
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.
Read more
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.
Read the detailed description
Study design: This is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the N-Tidal C data-collector capnometer in patients with COPD. Patients will be enrolled into one of two cohorts: community-based case managed patients with chronic hypercapnia, and hospitalised patients who have been admitted via the emergency room for the treatment of COPD-related ventilatory failure.
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12-18 months
To identify the within-day and day-to-day variability of exhaled carbon dioxide in patients with COPD.
Measured: 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.
Measured: 12-18 months
To capture the carbon dioxide signature predictive of exacerbation in monitored patients who undergo an acute admission during the study.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start17 Feb 2016
- Primary completion6 Jul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- TidalSense
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ravi Mahadeva, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814253
- Sponsor's protocol ID
- G001-15_CBRS
- Acronym
- CBRS
- Status last verified
- May 2023
- First submitted
- 23 Jun 2016
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: To be decided
Publications
Lim RH, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Neville DM, Wiffen L, Brown T; BRS Team; Vijaykumar E, Chauhan AJ, Patel AX. Quantification of smoking-related airway remodelling in COPD, using N-Tidal. Sci Rep. 2026 Feb 26;16(1):8713. doi: 10.1038/s41598-026-41699-6.
PubMed 41748706Talker 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.
PubMed 37268935
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Observational Clinical Evaluation of TidalSense's N-Tidal C Data-collector Capnometer to Collect Breathing Records in Patients With COPD
- ClinicalTrials.gov ID
- NCT02814253
- Acronym / sponsor ID
- CBRS / G001-15_CBRS
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TidalSenseIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 6 Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design: This is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the N-Tidal C data-collector capnometer in patients with COPD. Patients will be enrolled into one of two cohorts: community-based case managed patients with chronic hypercapnia, and hospitalised patients who have been admitted via the emergency room for the treatment of COPD-related ventilatory failure.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 men and women with a diagnosis of moderate to severe COPD.
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 4 months
4 secondary outcomes
To identify the correlation of carbon dioxide (CO2) measurements by capnography with those obtained by periodic standard arterial and capillary blood gas measurements.
Time frame: 12-18 months
To identify the within-day and day-to-day variability of exhaled carbon dioxide in patients with COPD.
Time frame: 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.
Time frame: 12-18 months
To capture the carbon dioxide signature predictive of exacerbation in monitored patients who undergo an acute admission during the study.
Time frame: 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Derived from this study: PubMed 41748706Lim RH, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Neville DM, Wiffen L, Brown T; BRS Team; Vijaykumar E, Chauhan AJ, Patel AX. Quantification of smoking-related airway remodelling in COPD, using N-Tidal. Sci Rep. 2026 Feb 26;16(1):8713. doi: 10.1038/s41598-026-41699-6.
- Derived from this study: PubMed 37268935Talker 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.
- Individual participant dataSharing planned: Undecided. To be decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Mahadeva principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by TidalSense at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.