Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance (PRIOD)
Primary Purpose
Swallowing Disorders
Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
respiratory plethysmography by inductance
Sponsored by
About this trial
This is an interventional diagnostic trial for Swallowing Disorders focused on measuring swallowing disorders, geriatrics
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
Sites / Locations
- University Hospital of Grenoble
Outcomes
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?
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?
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?
Full Information
NCT ID
NCT00827749
First Posted
January 22, 2009
Last Updated
July 21, 2010
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT00827749
Brief Title
Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance
Acronym
PRIOD
Official Title
Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorders
Keywords
swallowing disorders, geriatrics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
respiratory plethysmography by inductance
Intervention Description
contribution of respiratory plethysmography by inductance and informatic tool
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
State/Province
Cedex 09
Country
France
12. IPD Sharing Statement
Learn more about this trial
Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance
We'll reach out to this number within 24 hrs