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

Completed

• Conditions: Point of Care Monitoring

• Registration Number: NCT04531449
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

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.

Detailed 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™

Study Timeline

• Study Start: 2019-06-06
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Status Verified: 2020-08
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-08-28
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the usability of the Inflammacheck device in health care providers	immediately after the procedure	number of attempts taken to obtain a result

Trial Locations

Locations (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital; 🇬🇧 Portsmouth, Hampshire, United Kingdom