Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia

Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)

The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.

Study Overview

• Status: Completed
• Conditions: Stroke; Dysphagia
• Intervention / Treatment: Other: Cereal extract concentration 1; Other: Cereal extract concentration 2; Other: Cereal extract concentration 3; Other: Thicken up clear concentration 2; Other: Thicken up clear concentration 3; Other: Thicken up clear concentration 1

Detailed Description

This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit).

The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Charleroi, Belgium, 6000
    • Grand Hôpital de Charleroi
• France
  • Rouen, France, 76031
    • Centre Hospitalier Charles Nicolle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thicken Up Clear concentration 1; Thicken Up Clear at concentration 1	Other: Cereal extract concentration 1; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 2; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 3; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 2; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 3; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Active Comparator: Thicken Up Clear concentration 2; Thicken Up Clear at concentration 2	Other: Cereal extract concentration 1; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 2; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 3; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 3; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 1; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Active Comparator: Thicken Up Clear concentration 3; Thicken Up Clear at concentration 3	Other: Cereal extract concentration 1; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 2; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 3; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 2; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 1; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Experimental: Cereal extract concentration 1; Cereal extract at concentration 1	Other: Cereal extract concentration 2; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 3; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 2; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 3; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 1; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Experimental: Cereal extract concentration 2; Cereal extract at concentration 2	Other: Cereal extract concentration 1; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 3; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 2; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 3; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 1; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Experimental: Cereal extract concentration 3; Cereal extract at concentration 3	Other: Cereal extract concentration 1; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Cereal extract concentration 2; Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 2; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 3; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem; Other: Thicken up clear concentration 1; Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Subjective perception of ease of swallowing and oropharyngeal sensation.	This will be assessed from a questionnaire.	Right after ingredient ingestion, maximum during one hour.

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 13.21. NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO