Cardiorespiratory Diagnostic Study

NCT ID: NCT04939558

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 744 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2022-11-30

Brief Summary

This study uses a new breathing device called 'N-Tidal C' handset which measures breathing patterns. Investigators have found that people with cardiac and respiratory illnesses breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathed out CO2 (the waveform) varies according to the underlying health of the user's lungs. Monitoring these changes may help doctors to more accurately diagnose and monitor the most common and serious respiratory conditions.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is among the most prevalent respiratory conditions, and in the top five causes of death worldwide. However, mis-diagnosis rates are high (both under- and over- diagnosis), owing to the lack of a simple, reliable and specific diagnostic test. In addition, COPD is often diagnosed late in the natural history of the disease, which misses the opportunity for early intervention, with early treatment and health-behaviour changes (smoking cessation).

Spirometry, the current gold standard for diagnosis, is unreliable (technique-dependent), crude (measures airflow), and non-specific (multiple respiratory conditions can produce similar patterns on spirometry). It also relies on proper administration by specially trained members of staff. As a result, spirometry is often (a) not performed before a speculative diagnosis of COPD is made, and (b) performed poorly, resulting in poor-quality information on which to base a respiratory diagnosis.

There is therefore a need for a simple, reliable, robust and accurate test for diagnosing COPD which is non-operator dependent, and non-technique dependent.

Currently, capnography is invasive, expensive and can only be recorded in specialist centres via a nasal cannula and micro-stream sampling of expired carbon dioxide in the intensive care setting. The N-Tidal C (NTC) handset, a new (CE-marked), hand-held, wireless device has been developed to monitor the user's Tidal Breathing CO2 (TBCO2) waveforms at rest, during normal tidal breathing. This device can be safely operated in the home environment, has a battery life of weeks, and has an isolated, disposable, breath pathway that isolates an individual's breath from the rest of the device, making it safe to reuse between patients after the outer casing has been decontaminated using a 3-stage disinfection process.

The N-Tidal technology has the potential to offer new insights into lung physiology (above and beyond those currently available from spirometry and lung function testing), and early evidence from TidalSense's previous clinical studies suggests that the TBCO2 data could be used to fingerprint and diagnose COPD.

Conditions

COPD; Asthma; Lung Cancer; Anemia; Congestive Cardiac Failure; Bronchiectasis; Interstitial Lung Disease; Long COVID; Upper Respiratory Disease; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic Obstructive Pulmonary Disease

245 participants - GOLD 1, 2, 3 / A, B, C

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Asthma

55 participants - Mild to moderate, not labelled as severe.

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Congestive cardiac failure

55 participants

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Anaemia

55 participants - with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Bronchiectasis

55 participants - Acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Lung cancer

55 participants - including rare types e.g. mesothelioma

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Interstitial Lung Disease

55 participants - including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Long COVID

55 participants

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Upper airway obstruction disorder

55 participants

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Healthy

55 participants - with no previous or current chronic cardiorespiratory diagnoses

N-Tidal C handset

Intervention Type: DEVICE

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Interventions

N-Tidal C handset

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Healthy volunteer (with no previous or current chronic cardiorespiratory diagnoses)

One of the following cardiorespiratory diagnoses:

• COPD (GOLD 1, 2, 3 / A, B, C)*
• Asthma (mild to moderate, not labelled as severe)*
• Congestive cardiac failure*
• Anaemia (with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions)*
• Bronchiectasis (acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias)*
• Lung cancer (including rare types e.g. mesothelioma)*
• Interstitial Lung Disease (including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis)*
• Long COVID*
• Upper airway obstruction disorder*
• [Active pulmonary hypertension]
• [Extrinsic Allergic Alveolitis]
• [Active pulmonary embolism]

• Participants who are acutely unwell, e.g. active exacerbation, very short of breath e.g. severe COPD (GOLD 4 / D) or end-stage IPF.
• Inability to give written informed consent

Exclusion Criteria

• Participants who, in the opinion of the chief investigator, or their delegate, are unlikely to comply with the requirements of the study;
• Diagnosis of neuromuscular disorders;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innovate UK

OTHER_GOV

Sponsor Role: collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

TidalSense

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zishan Ali, MBBS BSc

Role: PRINCIPAL_INVESTIGATOR

Modality Partnership

Elango Vijaykumar, MBBS, FRCG

Role: PRINCIPAL_INVESTIGATOR

Modality Partnership

Locations

Modality Partnership

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Other Identifiers

G001-21

Identifier Type: -

Identifier Source: org_study_id