Clinical trial NCT00827749: Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance
Official title: Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Swallowing Disorders
Keywords: swallowing disorders
geriatrics
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the efficiency of a novel non-invasive method for swallowing disorders detection in geriatrics.

Detailed description: Interest: swallowing disorders exist at any age. More common among the elderly, their prevalence is estimated at between 15 and 50% of more than 60 years. Recognized today as a health problem of particular concern within this population, their pathological consequences are multiple and severe: inhalation pneumonia, often a complication of "the wrong track", was recognized in the USA in 1989, as 5th cause of death among patients aged 65, and the 3rd leading cause of death of patients over 85 years. Malnutrition facilitates infections by depression of the immune system and promotes the development of bedsores. The swallowing disorders resulting in an increase in the prevalence of dehydration, social isolation, but also an increase in mortality. Faced with such consequences, it is therefore necessary to have a reliable, non-invasive approach adapted to the fragility of the elderly to detect these disorders in order to promote preventive strategies and / or curative justified.

Originality: This work, which is part of a clinical approach uses a new method of swallowing study, described in A. Moreau-Gaudry's Medicine thesis : "Assets of the respiratory inductance plethysmography to the study of swallowing in geriatrics." The originality of this lies in the combination of Respiratory Plethysmography by inductance (RPI) to the informatic tool. The PRI allows continuous recording, thanks to a vest connected to a laptop, the patient's breathing rate. Readily available at the patient's bedside, it is non-invasive and perfectly suited to the fragility of the study population. The tool, by its automatic guarantees objectivity and reproducibility of the analysis of deglutitions from respiratory signal provided by the RPI.

Eligibility criteria: Inclusion Criteria:

* Patients major, consenting, cooperating.
* Person registered with the French Social Security or benefiting from an equivalent health insurance system

Exclusion Criteria:

* Patients do not qualify for inclusion pre-cited,
* Patients in a period of exclusion for other studies,
* Patients with behavioural problems that prevent them joining a clinical trial requiring prolonged collaboration (state of rest with minimal mobilization of the patient, a necessary condition to acquire a breathing rate of quality, and therefore an analysis of quality),
* Patient suffering from a nosocomial infection,
* Patient the acute stage of a condition involving the life of the latter,
* Patient insufficient breathing, oxygen, with respiratory failure poorly supported despite oxygen,
* Patient in respiratory failure decompensated
* Patient at the end of life

Primary outcomes:
measure: Can we detect with a non-invasive, infra clinical, objective and non-traumatic tool, a patient's deglutitions from an automatic analysis of a recording of his breathing rate?
timeFrame: 2.5 hours
Secondary outcomes:
measure: Can we detect with a non-invasive, infra clinical, objective and non-traumatic tool pathological deglutitions from an automatic analysis of a recording of his breathing rate?
timeFrame: 2.5 hours
measure: Can we have a test to classify patients into two groups - those without swallowing disorders and those with swallowing disorders - from an analysis of quantitative parameters relating to the analysis of the breathing rate?
timeFrame: 2.5 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
state: Cedex 09
Study officials:
References: