Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY, United Kingdom
NCT Number: NCT03356288
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.
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Notify Me16 year and older
All sexes
Observational
Portsmouth, Hampshire, PO6 3LY, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Asthma Cohort:
Breathing Pattern Disorder Cohort
Chronic heart failure Cohort:
Motor Neurone Disease Cohort:
Pneumonia Cohort:
Healthy Cohort:
Exclusion criteria
Time frame: 12 months
Time frame: Change measures - baseline to 6 months
Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months.
Time frame: 12 months
The Asthma Control Questionnaire Score for the Asthma patients
Time frame: 12 months
The Nijmegen Questionnaire Score
Time frame: 2 days
The CURB-65 Score
Time frame: 12 months
The Trans Thoracic Echocardiogram (TTE) result
Time frame: 12 months
The level of partial pressure carbon dioxide (pCO2)
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
Time frame: 12 months
Measured by a questionnaire of the participants experience of the device at the end of the study
TidalSense
Industry
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.
Acronym: GBRS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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