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| Name | Class |
|---|---|
| Pôle Saint Hélier | OTHER |
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The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician
The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician.
The study "RELIASEM" will study hospitalized patients with high risk of Pressure Injurieswith the next conditions:
For each patient 14 mesures: 6 on the sacrum, 4 on the right heel and 4 on the left heel. This set of measure will be realized 2 timesby 4 different evaluator. To will have been trained in the use of the SEM Scanner where as the other will be novice.
The main objective of this study is to determine on a risk population the intra- and inter-examiner reliability of the SEM Scanner
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sample for reliability | Other | Reliability and validity of SEM Scanner : intra rater, inter rater and inter novice/trained 8(2 trained rater, 2 novice rater, each one performed twice)measured will be performed on each patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEM Scanner | Diagnostic Test | They will perform 2 sets of 3 measures (1 on sacrum, 1 on the right heel and 1 on the left heel)for each patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced) | We will calculate the intra-class correlation coefficient (ICC) intra- and inter-evaluator (experienced vs experienced) | immediately after the intervention |
| Evaluation of the validity of the SEM Scanner on at risk population | Intra-class correlation coefficient is the correlation coefficient between SEM Scanner measure and the norton scare | immediately after the intervention |
| Evaluation of the validity of the SEM Scanner on at risk population | The Norton scale will be used by the study :Norton ≥ 18 low or without risk, 14< Norton <18 medium risk, 12≤ Norton ≤14 high risk, Norton < 12 very high risk | During the evaluation 1 day assessed |
| Measure | Description | Time Frame |
|---|---|---|
| valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated | The intra-class correlation coefficient (ICC) intra- and inter- evaluator (experienced vs novice/novice vs novice) will be calculated | immediately after the intervention |
| Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Gallien, Doctor | Contact | +33299295099 | philippe.gallien@pole-Sthellier.com | |
| Jean-Paul Haeberle | Contact | +33626742085 | jean-paul.haeberle@arjo.com |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Gallien, Doctor | Pôle Saint Hélier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pole Saint-Hélier | Recruiting | Rennes | Brittany Region | 35000 | France |
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The SEM Scanner is placed on three skin areas (left heel, right heel and sacrum). It measures the moisture of the subcutaneous tissues. If returns a figure wich induces a classification
For each patient 3 measurements will be performed. Two of them will have been trained in the use of the SEM Scanner, whereas the others will be novice
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AUC of the SEM Scanner for every cut of scores of the Norton score |
| immediately after the intervention |