Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - JUMPAIR (Decubitus Ulcers Diseases Diagnoses by means of Smart ICT Anti-Decubitus System based on known Ulcers Activity Biomarkers)

Teaser

Decubitus ulcers has major economic costs as well as heavy casualties for Europe. In Europe, the share of European health costs on the Gross Domestic Product (GDP) was 9,2% in 2012, so €1.493 billion. In Europe, overall DeU is estimated to cost to the European Public Health...

Summary

Decubitus ulcers has major economic costs as well as heavy casualties for Europe. In Europe, the share of European health costs on the Gross Domestic Product (GDP) was 9,2% in 2012, so €1.493 billion. In Europe, overall DeU is estimated to cost to the European Public Health System almost 0.1% of GDP for European countries, bringing annual costs to more than €16 billion. The financial cost of DeU in the EU is estimated to reach to the percentage of 1,1% of the total National Health Service (NHS) expenditure by 2020.
Currently, the global market for hospital beds is valued at €120,2 billion in 2015, and it is expected to high growth at a CAGR of 4,2% over the next 5 years amounting to €147,6 billion in 2020. Within the global hospital beds market, the current global market for therapeutic beds is valued at €94,6 billion, and it is expected to high growth at a CAGR of 5,7% over the next 5 years amounting to €124,9 billion in 2020. The estimated value of the European Market of therapeutic beds is of €9,6 billion in 2015 and of €12,7 billion in 2020. Spurred by the hefty bill and lack of resources, hospitals and in particular their Innovation Units are continuously looking for new strategies to minimize the incidence of DeU. Prevention and early diagnosis are the main priority with DeU. While 95% of all DeU are considered preventable, no concluding evidence exists that current devices are effective in the prevention of DeU. Indeed, 38,5% of DeU appeared while using any of current devices. Thus, the aim of this project is to take advantage of this niche market offering an innovative medical technologic device for the prevention, the early diagnosis and the suitable treatment of DeU diseases improving the living conditions of patients with reduced mobility.
The innovative JUMPAIR system offers a complete anti-decubitus system, but introduces the innovative presence of the patient and the mattress with a multi-parametric approach of bio-markers along with the high accuracy of medical equipment.
The JUMPAIR anti-decubitus bed binds its anti-decubitus action to the mechanical movement of plastic slats that move up and down, thus creating a longitudinal sine wave of amplitude no less than 15 cm, the movement is created by a camshaft with eccentrics positioned under the slats that allow the minimum separation of the patient-support surface of about 3 cm. The mechanism is regulated by 2 low voltage (24v) powered motors, this movement creates an alternating decompression on all body surfaces.
The movement of the staves has a double action: it decreases the pressure on the areas at risk and improves the blood supply, useful both to reparative processes and to prevention, without causing an increase in body temperature, which is harmful for Decubitus Ulcers (DeU).

Work performed

During the first year Dofren worked to produce the final prototypes that will provide to the clinical structures to carry out the clinical Trials.
From the beginning we studied and designed the pressure mattress mat and after the moisture sensor.
In cooperation with our subcontractor Sensing Tex, we designed the software able to collect data from the sensors.
After a couple of months, in which we made different protypes, at the end of August we made the first final prototype. In the months after we tested it and we improved it, to reach the final fully implemented version (Anti decubitus massage system, 3D mattresses with the ventilation system). Based on this last version we produced 21 prototypes for the Hospitals that have to start with the clinical trials.
In the meantime, we also designed the Clinical Protocol and we prepared all other documents for Notified Body (in our case the Italian Ministry of Health) and for the Hospital\'s Ethics Committees.
All the documents about the trials (RCT protocol, e-CRF, Informed consent and information data sheet, declarations of feasibility, declaration of absence of interest conflict, Instructions for Use, etc…) were submitted to the Ethics Committee of the involved clincial structures and to the Italian Ministry of Health and ahve been approved.

Final results

The anti-decubitus system JUMPAIR will benefit many patients who are suffering of decubitus ulcers (DeU) or they are running the risk to suffer it by an advanced DeU treatment providing alerts at critical situations by adoption of smart relevant ICT solutions for the Health, Well-being and Well-Ageing of patients. Additionally, JUMPAIR will also offer a rehabilitation program who suffered of DeU during bedding in their house or in the hospital. The final product will contribute to prevent DeU and to improve healthcare expenditure containment avoiding unnecessary hospitalizations and therapeutic treatments. We believe that there is an unmet need in that field to deliver new and more efficient care to European citizens, and the final systems allows a preventive and therapeutic care of DeU having great impact for physicians and patients who deal with this critical DeU disease.

We are ready to start the clinical trials in the 3 Hospitals. We will deliver the beds to each structure and provide the right training about the trial.
The objective of the clinical trial is to improve and validate clinically JUMPAIR, the no-invasive remote preventive, therapeutic and monitoring medical device for the early diagnoses of DeU to provide and monitor the efficacy of medical treatment. These evidences will be useful to apply for CE and FDA certification and to get both certifications within the end of Phase II and are underpin for the
The results will be important also for scientific publications and for the dissemination of the device in the medical field.

Website & more info

More info: http://www.jumpair.it/.