Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance (PRIOD)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00827749
First received: January 22, 2009
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Swallowing Disorders
Device: respiratory plethysmography by inductance
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD)

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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? [ Time Frame: 2.5 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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? [ Time Frame: 2.5 hours ] [ Designated as safety issue: Yes ]
  • 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? [ Time Frame: 2.5 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: respiratory plethysmography by inductance
    contribution of respiratory plethysmography by inductance and informatic tool
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00827749

Locations
France
University Hospital of Grenoble
Grenoble, Cedex 09, France
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Alexandre Moreau-Gaudry, University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT00827749     History of Changes
Other Study ID Numbers: DCIC 05 22
Study First Received: January 22, 2009
Last Updated: July 21, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
swallowing disorders
geriatrics

Additional relevant MeSH terms:
Disease
Deglutition Disorders
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014