Stroke Clinical Trial
Official title:
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)
Verified date | October 2017 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.
Status | Completed |
Enrollment | 35 |
Est. completion date | September 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale 2. Patients aged between 18 and 85 years 3. Ischemic/hemorrhagic cerebral cause (stroke) 4. Able to understand French (oral and written) 5. Cognitive capacity enough to understand study procedures 6. Having health insurance (which in France is " social security") 7. Having signed the consent form. Exclusion Criteria: 1. Any swallowing trouble not resulting from the current stroke 2. History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system 3. Any physician diagnosed psychiatric illness 4. Patient with a digestive fistula 5. Any physician diagnosed food allergy 6. Any known allergy to barium or any compound of the contrast product 7. Confirmed or suspected perforated and occlusive syndrome 8. Pregnant or lactating women 9. Major respiratory disease needing oxygen (chronic respiratory insufficiency) 10. Subject who cannot be expected to comply with the study procedures, including consuming the test products. 11. Currently participating or having participated in another clinical trial during the month preceding the study |
Country | Name | City | State |
---|---|---|---|
Belgium | Grand hopital de Charleroi | Charleroi | |
France | Centre Hospitalier Charles Nicolle | Rouen |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
Belgium, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of any systematic effect of cohesiveness on the efficacy of swallowing in dysphagic patients according to Rosenbek's Penetration-Aspiration Score (PAS) using videofluoroscopy | The PAS score across each bolus (5 mL and 10 mL) | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing safety- prevalence of penetration | The prevalence of penetration in the population according to Rosenbek's PAS (score of 2-5) assessed using videofluoroscopy | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing safety- prevalence of aspiration | The prevalence of aspiration in the population according to Rosenbek's PAS (score of 6-8) assessed using videofluoroscopy | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function- Amount/volume of oral and pharyngeal residues | The amount/volume of oral and pharyngeal residues assessed using videofluoroscopy | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function- Prevalence of subjects with oral and pharyngeal residues | The prevalence of subjects of oral and pharyngeal residues assessed using videofluoroscopy | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function- Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible) | Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible) | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function- Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing) | Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing) | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function- Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter) | Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter) | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function- Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter) | Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter) | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function-Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing) | Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing) | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Swallowing function- Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure) | Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure) | During the ingestion (videofluoroscopy), maximum during one hour. | |
Secondary | Subjective perception of ease of swallowing and oropharyngeal sensation. | This will be assessed from a questionnaire. | Right after ingredient ingestion, maximum during one hour. |
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