Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance (PRIOD)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 22, 2009 |
| Last Updated Date | July 21, 2010 |
| Start Date ICMJE | November 2008 |
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00827749 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
|
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance |
| Official Title ICMJE | Contribution of Respiratory Plethysmography by Inductance and of Informatic Tool for the Study of Swallowing Disorders in Geriatrics (PRIOD) |
| 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. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 0 |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Condition ICMJE | Swallowing Disorders |
| Intervention ICMJE | Device: respiratory plethysmography by inductance
contribution of respiratory plethysmography by inductance and informatic tool |
| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 30 |
| Completion Date | June 2010 |
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | France |
| Administrative Information | |
| NCT Number ICMJE | NCT00827749 |
| Other Study ID Numbers ICMJE | DCIC 05 22 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Dr Alexandre Moreau-Gaudry, University Hospital of Grenoble |
| Study Sponsor ICMJE | University Hospital, Grenoble |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University Hospital, Grenoble |
| Verification Date | July 2010 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|