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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03650686
Other study ID # Buisson PHRIP 2017 PAMPILLE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 3, 2018
Est. completion date December 2019

Study information

Verified date August 2018
Source Centre Hospitalier Universitaire Dijon
Contact Corinne BUISSON
Phone +33 380293776
Email corinne.buisson@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Malnutrition affects 50% to 70% of hospitalized elderly people, and is all the more worrying in the elderly because of its clinical impact. A measurement of food consumption is essential to recognize needs, monitor the nutritional status of the elderly in hospital and implement specific therapeutic action such as supplements or an increase in energy-protein to combat malnutrition or the risk of malnourishment. Unfortunately, this measure is rarely done effectively in practice, keeping the patient in nutritional deficit, contributing to a risk of increased morbidity and mortality.

Although weighing food intake is the reference method, it is a routine burden for healthcare teams. To overcome these constraints in hospital environments, intake is estimated by food readings over three consecutive days using a semi-quantitative method. It should be noted that this method remains complex, imprecise and reserved only for the most malnourished patients. In recent years, the development of photographic methods has become an interesting alternative to the measurement by weight. Based on photographs taken before and after the meal in order to deduce what is actually ingested, these methods obtain results comparable to the weighing method, though there is still a number of limitations (need for human intervention, constraint to have standardized menus in weight and lack of nutritional management adapted to patients). To overcome these limitations, an automated photographic method based on modern techniques for automatic processing of 2D and 3D images coupled with techniques derived from artificial intelligence has recently been developed in the investigator's unit, but has not yet been validated.

The originality and innovation of this project lies in the automated analysis of the photos taken and the conversion into percentage of remaining food thanks to the design of algorithms for image preprocessing and neural classification by a 2D and 3D software (patent pending).


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 2019
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient who has given oral consent to participate

- adult patient

- inpatient geriatric rehabilitation follow-up care (SSRG) and acute geriatric units

- patient eating alone or with help

Exclusion Criteria:

- patient with enteral or parenteral nutrition

- patient not affiliated to a social security scheme

- end-of-life patient or palliative care

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food weighing (gold standard)
Method which consists in weighing precisely the main dish at the beginning and then end of meal using a SOEHNLE scale (+/- 1g).
Automated photographic method (method to be evaluated)
The nursing staff will position the tray for automatic picture taking before and after the meal. Taking a photograph of the entire tray will allow the patient's identity to be identified by his meal card which will then be coded for analysis and the plate will be targeted at the time of the nutritional analysis by the software. This method will automatically provide the percentage of each main dish food consumed using an advanced image processing algorithm and an optimized artificial intelligence system that will recognize the food before and after consumption. Automatic processing and transfer will enable food intake to be collected.
Semi-quantitative method (routine method)
Staff will indicate whether 1, ¾, ½, ¼ or 0 (corresponding to 100%, 75%, 50% 25% or 0) of the food in the main course has been consumed.

Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average percentage quantification of ingesta Over 3 consecutive days
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