Status:
COMPLETED
The General Breathing Record Study
Lead Sponsor:
TidalSense
Collaborating Sponsors:
Innovate UK
Conditions:
Asthma
Heart Failure
Eligibility:
All Genders
16+ years
Brief Summary
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also ev...
Detailed Description
When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or "waveform". This waveform can tell a clinician a...
Eligibility Criteria
Inclusion
- Asthma Cohort:
- A confirmed clinical diagnosis of asthma for ≥ 6months
- Moderate to severe asthma defined as British Thoracic Society stages 3-5
- 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months.
- Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics).
- Breathing Pattern Disorder Cohort
- A Clinical diagnosis of a Breathing Pattern Disorder (BPD)
- Chronic heart failure Cohort:
- A confirmed clinical diagnosis of chronic heart failure with both of the following:
- A Left Ventricular Ejection Fraction \<40% on most recent imaging within the last 12 months.
- New York Heart Association Class 2-4
- Admitted with an acute decompensation of their heart failure to hospital within the last 6 months
- Motor Neurone Disease Cohort:
- A confirmed clinical diagnosis of Motor Neurone Disease
- Forced Vital Capacity (FVC) of less than 60% of predicted, sleep disordered breathing or daytime hypercapnia.
- Established on Home Non-Invasive Ventilation.
- Pneumonia Cohort:
- A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging.
- Healthy Cohort:
- No known history of lung, cardiac or neuromuscular disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung, cardiac or neuromuscular disease). A Body Mass Index of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history.
Exclusion
- Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or Tidal Breath Carbon Dioxide measurements.
- In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.
Key Trial Info
Start Date :
August 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 4 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03356288
Start Date
August 9 2017
End Date
July 4 2018
Last Update
September 20 2018
Active Locations (1)
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1
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY