Validation of the software for arterial blood sample analysis _ V1
Research type
Research Study
Full title
Validation of the software for the automatic analysis e interpretation of the arterial blood sample as point-of care_V1
IRAS ID
272947
Contact name
Sancho Rodriguez-Villar
Contact email
Sponsor organisation
N/A
Clinicaltrials.gov Identifier
IRAS Project ID: 272947, IRAS Project ID: 272947
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
The Arterial blood gas (ABG) is a useful test that estimates the acid-base status and gas exchange of the patients. Based on this, we have created an algorithm translated into a (software) which provide to the clinician with with the differential diagnosis and potential list of causes of the identified disorder/s. which has got exclusive safety features such as an analysis of the internal consistency of the results and identification of life-threatening situations.
However, numerically reported test results to make rapid interpretation difficult on the bedside. To overcome this problem, we have developed software that automatically interprets the results.
We hypothesize that the use of this software is clinically accurate and therefore to validate it. For that will compare the output from the software with the "Gold standard" against two different Senior Clinical diagnoses. The algorithm not used for actual clinical diagnosis but to compare the results from the app to actual diagnosis to see how accurate it is. This way it will not been seen as a device as it is not used by clinicians.
It is an observational multicentre, prospective international study of routinely collected clinical data (results from routine arterial blood gases and biochemistry of the patient). This study does not suggest any treatment.The study will be conducted in only one NHS Trust. Across King's College NHS Foundation Trust. Other centres in Europe, each of these other centres will follow their own research approval and ethical consents localy.
Data will be collected prospectively, sourced from the medical notes and charts and collected by the direct care team. No intervention or additional tests to be done for this study.
This study of the software IS NOT considered as "medical device" because it DOES NOT suggest a possible diagnosis or treatment to the clinician.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1960
Date of REC Opinion
11 Dec 2019
REC opinion
Unfavourable Opinion