NCT03356288

The General Breathing Record Study

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: TidalSense · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Timeline

• Start date: 2017-08-09
• Primary completion: 2018-07-04
• Completion: 2018-07-04
• First posted: 2017-11-29
• Last updated: 2018-09-20

Locations

1 site across 1 country: United Kingdom