Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565587
Status:
UNKNOWN
Last Update Posted:
2021-09-09
First Post:
2020-08-25
Brief Title:
Dose-response Effect of the Thickener Tsururinko Quickly
Sponsor:
Morinaga Milk Industry Co LTD
Organization:
Morinaga Milk Industry Co LTD
Study Overview
Official Title:
Rheological Characterization of the Thickener Tsururinko Quickly and Dose-response Effect on Older Patients
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5819
Brief Summary:
Thickening fluids are a valid therapeutic strategy to improve safe swallowing in OD The aim of this study is to assess the percentage of safe swallowing at different viscosity levels thickened with Tsururinko Quickly
This study is designed to assess the therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100 200 400 800 1600mPas against thin liquid and between all the viscosity levels in older patients with Oropharyngeal Dysphagia OD by performing a Videofluoroscopy when swallowing As all patients will start with thin liquid each patient will be its own control To analyze the effect of the salivary amylase on the thickener participants will be asked to maintain two boluses 200 and 800mPas prepared jut with mineral water in the oral cavity for 30seconds After that period boluses will be analyzed by a viscometer and compared to those without oral incubation
This study is designed to assess the therapeutic effect on safety and efficacy of swallow of Tsururinko Quickly for the levels of viscosity 100 200 400 800 1600mPas against thin liquid and between all the viscosity levels in older patients with Oropharyngeal Dysphagia OD by performing a Videofluoroscopy when swallowing As all patients will start with thin liquid each patient will be its own control To analyze the effect of the salivary amylase on the thickener participants will be asked to maintain two boluses 200 and 800mPas prepared jut with mineral water in the oral cavity for 30seconds After that period boluses will be analyzed by a viscometer and compared to those without oral incubation
Detailed Description:
Older patients who fulfil the eligibility criteria are invited to participate in the study After having signed informed consent participants who meet the inclusion and exclusion criteria will a screening procedure V-VST Viscosities for the V-VST 50 200mPas and 800mPas Two questions will be performed to the patient on palatability and acceptability Palatability will be assessed by the 5-points hedonic scale and acceptability with the Scorecard - Food Action Rating Test After it a Videofluoroscopy VFS will be performed For the VFS participants will swallow 10mL boluses by duplicate of thin liquid and 5 different thickened viscosities of Tsururinko Quickly 1600 800 400 200 and 100 mPas with a stablished safety rule when the subject aspirates at the first bolus of thin liquid the second volume will not be given and the measurements will continue with the thickened varieties to the thinnest viscosity In case the subject aspirates at one thickened bolus the VFS ends for this specific patient As all patients will start with thin liquid each patient will be its own control with the non-thickened viscosity vs the others in order to establish the safety of swallow for all the levels performed Patients swallow will be studied with VFS in a lateral projection and images will include the oral cavity pharynx larynx and cervical oesophagus After each bolus the patient will be asked to give their opinion on the palatability of this specific bolus
Before VFS a bolus of 200 and 800mPas without contrast will be given to the participant in order to perform the oral incubation analysis Participants should keep the bolus in their mouth for 30 and then spit it out The bolus is then analysed with the viscometer at the shear rate of 50s-1 estimated value at the oral cavity and 300s-1 estimated value at the pharynx Viscosity values will be compared to the viscosity values without oral incubation The day after the completion of the VFS participants will be asked by phone for AE
Before VFS a bolus of 200 and 800mPas without contrast will be given to the participant in order to perform the oral incubation analysis Participants should keep the bolus in their mouth for 30 and then spit it out The bolus is then analysed with the viscometer at the shear rate of 50s-1 estimated value at the oral cavity and 300s-1 estimated value at the pharynx Viscosity values will be compared to the viscosity values without oral incubation The day after the completion of the VFS participants will be asked by phone for AE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None