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
|Condition or disease|
|Asthma Heart Failure Pneumonia Motor Neuron Disease Vocal Cord Dysfunction Breathlessness|
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|
|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|
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
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.
10 Participants who have no known lung, cardiac or neuromuscular condition.
- The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device [ Time Frame: 12 months ]
- 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.
- Disease Control in asthma patients [ Time Frame: 12 months ]The Asthma Control Questionnaire Score for the Asthma patients
- Disease Improvement in Breathing Pattern Disorder patients [ Time Frame: 12 months ]The Nijmegen Questionnaire Score
- Disease severity in the pneumonia patients [ Time Frame: 2 days ]The CURB-65 Score
- Disease severity in heart failure patients [ Time Frame: 12 months ]The Trans Thoracic Echocardiogram (TTE) result
- Hypercapnia in the motor neurone disease patients [ Time Frame: 12 months ]The level of partial pressure carbon dioxide (pCO2)
- 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
- 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
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
|Portsmouth Hospitals NHS Trust|
|Portsmouth, Hampshire, United Kingdom, PO6 3LY|
|Principal Investigator:||Anoop J Chauhan, PhD||Portsmouth Hospitals NHS Trust|