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The General Breathing Record Study (GBRS)

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ClinicalTrials.gov Identifier: NCT03356288
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Innovate UK
Information provided by (Responsible Party):
Cambridge Respiratory Innovations Limited

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 evaluate whether this device can detect when a person's breathing problem is getting worse.

Condition or disease
Asthma Heart Failure Pneumonia Motor Neuron Disease Vocal Cord Dysfunction Breathlessness

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 lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform.

This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.


Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Proof-of-concept Study to Explore the Waveform Characteristics of Tidal Breathing Carbon Dioxide (CO2), Measured Using the N-Tidal C™ Device, in Different Breathing Conditions.
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : July 4, 2018

Group/Cohort
Asthma
20 Participants with moderate to severe asthma, as defined by British Thoracic Society (BTS) guidelines
Chronic heart failure
10 Participants with a diagnosis of chronic heart failure
Breathing Pattern Disorder
10 Participants with a diagnosis of Breathing Pattern Disorder
Pneumonia
10 participants with a radiologically confirmed diagnosis of pneumonia
Motor Neurone Disease
10 participants with a diagnosis of motor neurone disease with known hypercapnic failure.
Healthy
10 Participants who have no known lung, cardiac or neuromuscular condition.



Primary Outcome Measures :
  1. The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in the Tidal Breathing carbon dioxide waveform over time [ Time Frame: Change measures - baseline to 6 months ]
    Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months.

  2. Disease Control in asthma patients [ Time Frame: 12 months ]
    The Asthma Control Questionnaire Score for the Asthma patients

  3. Disease Improvement in Breathing Pattern Disorder patients [ Time Frame: 12 months ]
    The Nijmegen Questionnaire Score

  4. Disease severity in the pneumonia patients [ Time Frame: 2 days ]
    The CURB-65 Score

  5. Disease severity in heart failure patients [ Time Frame: 12 months ]
    The Trans Thoracic Echocardiogram (TTE) result

  6. Hypercapnia in the motor neurone disease patients [ Time Frame: 12 months ]
    The level of partial pressure carbon dioxide (pCO2)

  7. Usability of the N-Tidal C device [ Time Frame: Change measures - baseline to 6 months ]
    Measured by how frequently the patients remember to use the N-Tidal C device over 6 months

  8. Acceptability of the N-Tidal C device [ Time Frame: 12 months ]
    Measured by a questionnaire of the participants experience of the device at the end of the study



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The healthy Cohort will be made up of healthy volunteers. The Disease Cohorts will be selected from hospital outpatient clinic lists and inpatient wards.
Criteria

Inclusion Criteria:

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:

    1. A Left Ventricular Ejection Fraction <40% on most recent imaging within the last 12 months.
    2. 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356288


Locations
United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Sponsors and Collaborators
Cambridge Respiratory Innovations Limited
Innovate UK
Investigators
Principal Investigator: Anoop J Chauhan, PhD Portsmouth Hospitals NHS Trust

Responsible Party: Cambridge Respiratory Innovations Limited
ClinicalTrials.gov Identifier: NCT03356288     History of Changes
Other Study ID Numbers: G002-17_GBRS
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cambridge Respiratory Innovations Limited:
Capnography, Diagnosis. Breathlessness, Exacerbations, Device

Additional relevant MeSH terms:
Heart Failure
Pneumonia
Motor Neuron Disease
Dyspnea
Vocal Cord Dysfunction
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Laryngeal Diseases
Otorhinolaryngologic Diseases