COPD Breathing Record Study 2

NCT03615365 | Completed

• 1 other identifier: G007-17_CBRS2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). The patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. The data will also be examined to assess the predictive possibility of a non-invasive self-care personal CO2 monitoring device to identify COPD exacerbations.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Capnography; Diagnosis; Breathlessness; Exacerbations; Device

Outcome Measures

Primary Outcomes (4)

• To measure the changes in the α angle of the tidal breathing CO2 (TBCO2) waveform data from stable COPD through an exacerbation and back to stable.

  The α angle is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. The α angle is given in degrees and significant changes in the α angle have previously been observed between stable COPD and acute exacerbations of COPD.

  Throughout the 26 week use of the N-Tidal C device for each patient.

• To measure the minimum and maximum CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.

  The minimum and maximum CO2 levels are key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.

  Throughout the 26 week use of the N-Tidal C device for each patient.

• To measure the variability of breath length of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.

  The variability of breath length is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. Breath length is measured in seconds and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.

  Throughout the 26 week use of the N-Tidal C device for each patient.

• To measure the standard deviation of End Tidal CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.

  The standard deviation of End Tidal CO2 levels is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. End Tidal CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.

  Throughout the 26 week use of the N-Tidal C device for each patient.

Secondary Outcomes (5)

• Longitudinal Database

  Throughout the 26 week use of the N-Tidal C device for each patient.

• COPD Exacerbations

  Throughout the 26 week use of the N-Tidal C device for each patient.

• COPD Variability

  Throughout the 26 week use of the N-Tidal C device for each patient.

• Usability of the N-Tidal C device

  Throughout the 26 week use of the N-Tidal C device for each patient.

• Acceptability of the N-Tidal C device

  At the end of the 26 week use of the N-Tidal C device for each patient.

Study Arms (1)

Patients with moderate-to-severe COPD.

Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) will be identified from the Cambridge COPD Centre. Those patients with COPD satisfying the inclusion criteria will be invited to participate. The majority of these will be GOLD D.

You may qualify if:

• Aged 40 years and over.
• Diagnosis of COPD (Primary) and at least one moderate exacerbation within 12 months of the start of the study period.
• Able to provide signed informed consent.

You may not qualify if:

• 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;
• Diagnosis of neuromuscular disorders or Kyphoscoliosis;
• Diagnosis of other Respiratory disorders that, in the opinion of the investigator, would impact the conduct of the study e.g. clinically significant bronchiectasis, asthma;
• Patients who have experienced an exacerbation of their COPD that has required treatment with antibiotics and/or oral corticosteroids within 2 weeks prior to the study start.

Sponsors & Collaborators

• TidalSense: lead

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; Disease; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Ravi Mahadeva

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 3, 2018
• Study Start: August 15, 2017
• Primary Completion: October 18, 2018
• Study Completion: November 23, 2018
• Last Updated: June 2, 2023

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)