Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance

Swallowing Disorders Clinical Trial

— PRIOD  

Official title:

Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827749
• Other study ID #: DCIC 05 22
• Status: Completed
• Phase: Phase 0
• First received: January 22, 2009
• Last updated: July 21, 2010
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Disorders

Intervention

Device:
• respiratory plethysmography by inductance
contribution of respiratory plethysmography by inductance and informatic tool

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble	Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?		2.5 hours	Yes
Secondary	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?		2.5 hours	Yes
Secondary	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?		2.5 hours	Yes

External Links

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