Cardiorespiratory Diagnostic Study (CARES)

T

TidalSense

Status

Completed

Conditions

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

Treatments

Device: N-Tidal C handset

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04939558
G001-21

Details and patient eligibility

About

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.

Full 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.

Enrollment

744 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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]

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;
  • Concurrent diagnosis of cardiorespiratory conditions (other than those listed in the inclusion criteria above) that, in the opinion of the chief investigator, would impact the conduct of the study
  • 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

Trial design

744 participants in 10 patient groups

Chronic Obstructive Pulmonary Disease
Description:
245 participants - GOLD 1, 2, 3 / A, B, C
Treatment:
Device: N-Tidal C handset
Asthma
Description:
55 participants - Mild to moderate, not labelled as severe.
Treatment:
Device: N-Tidal C handset
Congestive cardiac failure
Description:
55 participants
Treatment:
Device: N-Tidal C handset
Anaemia
Description:
55 participants - with at least 50% of participants recruited having no history of chronic cardiorespiratory conditions
Treatment:
Device: N-Tidal C handset
Bronchiectasis
Description:
55 participants - Acquired or genetic, e.g. cystic fibrosis or other primary ciliary dyskinesias
Treatment:
Device: N-Tidal C handset
Lung cancer
Description:
55 participants - including rare types e.g. mesothelioma
Treatment:
Device: N-Tidal C handset
Interstitial Lung Disease
Description:
55 participants - including pulmonary fibrosis pneumoconiosis, asbestosis, sarcoidosis, amyloidosis
Treatment:
Device: N-Tidal C handset
Long COVID
Description:
55 participants
Treatment:
Device: N-Tidal C handset
Upper airway obstruction disorder
Description:
55 participants
Treatment:
Device: N-Tidal C handset
Healthy
Description:
55 participants - with no previous or current chronic cardiorespiratory diagnoses
Treatment:
Device: N-Tidal C handset

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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