EXhaled Hydrogen Peroxide As a Marker of Lung Disease Study - Conformité Européenne (European Conformity) (EXHALE CE)

Portsmouth Hospitals NHS Trust

Status: Completed

Conditions: Point of Care Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04531449

PHT/2019/44

Details and patient eligibility

About

This study is designed to test whether the Inflammacheck™ device is easy to use by healthcare professionals who would be using it in a clinic setting or in primary care. The data collected during this study will be used as part of the evidence needed to get the CE (Conformité Européenne) marking for the device.

CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). CE marking is essential for any medical devices used in the UK or the EU.

Full description

This observational study has been designed to evaluate the ability of healthcare providers to use the Inflammacheck™, an investigational medical device, to measure participants exhaled breath condensate (EBC) H2O2. The data will be used to support the CE marking of the Inflammacheck™ device.

A measure of the participants' EBC H2O2 will be measured on the Inflammacheck™ device to demonstrate usability and comprehension of the instructions for use.

There are no control measurements involved in the study, all of the participants' EBC H2O2 measurements will be performed using Inflammacheck™ only.

Only healthcare providers naïve to the Inflammacheck™ device will be eligible to take part in the assessment of usability. This is to ensure that the usability assessment will not be biased by prior knowledge of the device or its instructions. The only training provided will be an introductory presentation explaining the Clinical Investigation objectives.

The total time for participant involvement is one session comprising of:

• Information & consent
• EBC H2O2 measurement with Inflammacheck™

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female, aged 18 years or above.
• Member of NHS staff at PHT.
• Is a healthcare provider.
• Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria

• In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
• Unable to comprehend the study and provide informed consent e.g. insufficient command of English in the absence of someone to adequately interpret.