The General Breathing Record Study (GBRS)

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.

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pneumonia; Motor Neuron Disease; Asthma; 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
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Tidal Breathing carbon dioxide waveform over time	Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months.	Change measures - baseline to 6 months
Disease Control in asthma patients	The Asthma Control Questionnaire Score for the Asthma patients	12 months
Disease Improvement in Breathing Pattern Disorder patients	The Nijmegen Questionnaire Score	12 months
Disease severity in the pneumonia patients	The CURB-65 Score	2 days
Disease severity in heart failure patients	The Trans Thoracic Echocardiogram (TTE) result	12 months
Hypercapnia in the motor neurone disease patients	The level of partial pressure carbon dioxide (pCO2)	12 months
Usability of the N-Tidal C device	Measured by how frequently the patients remember to use the N-Tidal C device over 6 months	Change measures - baseline to 6 months
Acceptability of the N-Tidal C device	Measured by a questionnaire of the participants experience of the device at the end of the study	12 months

Collaborators and Investigators

• Sponsor: Cambridge Respiratory Innovations Limited
• Collaborators: Innovate UK
• Investigators: Principal Investigator: Anoop J Chauhan, PhD, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): July 4, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Capnography, Diagnosis. Breathlessness, Exacerbations, Device
• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neuromuscular Diseases; Otorhinolaryngologic Diseases; Neurodegenerative Diseases; Signs and Symptoms, Respiratory; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Laryngeal Diseases; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Dyspnea; Vocal Cord Dysfunction
• Other Study ID Numbers: G002-17_GBRS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No