The General Breathing Record Study

NCT03356288 | Completed

• 1 other identifier: G002-17_GBRS
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Heart Failure; Pneumonia; Motor Neuron Disease; Vocal Cord Dysfunction; Breathlessness

Keywords

Capnography, Diagnosis. Breathlessness, Exacerbations, Device

Outcome Measures

Primary Outcomes (1)

• The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device

  12 months

Secondary Outcomes (8)

• Change in the Tidal Breathing carbon dioxide waveform over time

  Change measures - baseline to 6 months

• Disease Control in asthma patients

  12 months

• Disease Improvement in Breathing Pattern Disorder patients

  12 months

• Disease severity in the pneumonia patients

  2 days

• Disease severity in heart failure patients

  12 months

Study Arms (6)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Asthma Cohort:
• A confirmed clinical diagnosis of asthma for ≥ 6months
• Moderate to severe asthma defined as British Thoracic Society stages 3-5
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TidalSense: lead
• Innovate UK: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (1)

• Talker L, Neville D, Wiffen L, Selim AB, Haines M, Carter JC, Broomfield H, Lim RH, Lambert G; BRS Study Team; Weiss ST, Hayward G, Brown T, Chauhan A, Patel AX. Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer. Respir Res. 2023 Jun 2;24(1):150. doi: 10.1186/s12931-023-02460-z.

  PMID: 37268935 DERIVED

MeSH Terms

Conditions

Asthma; Heart Failure; Pneumonia; Motor Neuron Disease; Vocal Cord Dysfunction; Dyspnea

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Laryngeal Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anoop J Chauhan, PhD

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: November 29, 2017
• Study Start: August 9, 2017
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

GB (1)