Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06163118
Other study ID # 21_RIPH2-14
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 12, 2023
Est. completion date December 20, 2024

Study information

Verified date November 2023
Source University Hospital Center of Martinique
Contact Seendy Bartholet, PhD
Phone 05 96 55 11 76
Email seendy.bartholet@chu-martinique.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the mouth and the stomach, sometimes with falsities. These disorders can be the cause of a loss of appetite and a reduction in food consumption in older people. In the most serious cases, they can lead to aspiration, weakening the pulmonary passages and possibly leading to suffocation. Swallowing disorders constitute an important public health problem due to their prevalence among the elderly. Many early readmissions could be avoided thanks to better quality of care in these patients. In the elderly, the number of comorbidities and the multiplicity of medications and drug intake increase the incidence of swallowing disorders in this population. They constitute a common pathology, probably underestimated and underdiagnosed in the geriatric population. Given the aging of the Martinique population, it is appropriate to offer an easy-to-use, quickly achievable tool for diagnostic purposes, making it possible to quickly identify potential swallowing disorders, and therefore to anticipate meal intake, and on the adaptation of the prescription to a medicinal alternative (before any food or medication taken during hospitalization). In the Geriatric Short-Stay Unit of the Martinique University Hospital, a tool called "Deglut'G", was developed, and has been used since 2015, in order to allow caregivers a rapid, reliable and relevant assessment of swallowing disorders in the elderly, in order to guide care and medication alternatives.It now appears important to validate this tool, by comparing it with the results of examinations of swallowing disorders obtained from a speech-language pathologists (SLPs) and an ENT doctor.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 20, 2024
Est. primary completion date December 20, 2024
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Person aged 75 or over hospitalized in the Geriatric Short-Stay Unit, - Person having been informed of the research, - Person having given free written and informed consent, - Person affiliated to a social security scheme. Exclusion Criteria: - Person unable to take the tests, - Person with an oral condition that hinders normal swallowing (stomatitis, gingivitis, etc.), - Elderly person under legal protection, under guardianship or curatorship, - Person who refused to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Deglut'G test
Two tests to assess swallowing disorders using the Deglut'G tool will be carried out by a nurse or a caregiver from the Geriatric Short-Stay Unit, at visit 1. The tests can be taken successively, or spaced apart by a time defined by the medical team, and will be taken blind to each other. The average test administration time will be measured during the study, but the test should not exceed 10 minutes depending on the patients. The Deglut'G tool consists of an initial administration of gelled water (1 to 3 teaspoons), to identify if a cough occurs. In the event of a cough, the oral treatment is stopped; if the cough is absent, a new step this time consists of the administration of water (1 to 3 sips). In case of cough, the food will be mixed, the liquids thickened, and the medicinal treatments crushed. If there is no cough, foods and liquids can be taken as normal.
SLP swallowing test
At visit 1, 1 to 2 hours after the last Deglut'G test, a second swallowing test will be carried out by a SLP according to his skills and according to his usual practice, independently of the Deglut'G tool. This test should not exceed 20-30 minutes depending on the patient.
ENT doctor swallowing test
At Visit 2 (day 7 +/- 3 days after the inclusion), still as part of the short-stay hospitalization, the patient will meet an ENT doctor who will carry out an examination aimed at detecting swallowing disorders, according to his usual practice, of independent of the Deglut'G tool. The examination should not exceed 20-30 minutes depending on the patient.

Locations

Country Name City State
France University Hospital Center of Martinique Fort-de-France

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure the concordance between the results of the SLP examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders. Concordance between the results of the Deglut'G test and the SLP assessment.
The evaluation of a swallowing disorder via the DegluT'G tool, by the geriatric short-stay unit caregivers, will be done as follows:
Presence of cough following administration of gelled water : suspicion of swallowing disorder
Presence of cough following administration of water : suspicion of swallowing disorder
Absence of cough following administration of water : no swallowing disorder
This assessment will be compared to the SLP assessment, whatever the assessment method used.
12 months
Secondary Measure the concordance between the results of the ENT doctor examination, and those obtained with the Deglut'G tool, for the detection of swallowing disorders Concordance between the results of the Deglut'G test and the ENT doctor assessment.
The evaluation of a swallowing disorder via the DegluT'G tool, by the geriatric short-stay unit caregivers, will be done as follows:
Presence of cough following administration of gelled water : suspicion of swallowing disorder
Presence of cough following administration of water : suspicion of swallowing disorder
Absence of cough following administration of water : no swallowing disorder
This assessment will be compared to the ENT doctor assessment, whatever the assessment method used.
12 months
Secondary Measure the concordance of the measurements obtained with the Deglut'G tool between two caregivers, for the detection of swallowing disorders Inter-rater reliability of Deglut'G screening 12 months
Secondary Estimate the average time it takes to use the Deglut'G tool Time taken to take the Déglut'G tests (in minutes) 12 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03711474 - Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal) Phase 4
Enrolling by invitation NCT04074356 - Non-invasive Markers of Esophageal Function in Adults N/A
Suspended NCT04349462 - Post Critical Illness Dysphagia in the Intensive Care Unit N/A
Not yet recruiting NCT05982977 - Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT03455608 - PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer N/A
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Recruiting NCT03682081 - Interventions for Patients With Alzheimer's Disease and Dysphagia N/A
Completed NCT05700838 - Refining Cough Skill Training in Parkinson's Disease and Dysphagia Phase 1
Not yet recruiting NCT04064333 - Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care N/A
Not yet recruiting NCT02724761 - Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion N/A
Completed NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Completed NCT01919112 - Fostering Eating After Stroke With Transcranial Direct Current Stimulation N/A
Completed NCT01370083 - Tongue Pressure Profile Training for Dysphagia Post Stroke Phase 2
Completed NCT01723358 - Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia Phase 2
Withdrawn NCT01200147 - Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation N/A
Completed NCT00570557 - Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia N/A
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Completed NCT01476241 - Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist N/A
Completed NCT00717028 - Functional Endoscopic Evaluation of Swallowing N/A