UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050849 |
|---|---|
| Receipt number | R000057773 |
| Scientific Title | Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/05/17 11:43:29 |
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Basic information
Public title
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Acronym
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Scientific Title
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Scientific Title:Acronym
Association of videoendoscopic evaluation of swallowing and oral intake at discharge: retrospective study for cervical spinal cord patients
Region
| Japan |
Condition
Condition
cervical spinal cord injury patients
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the detail characteristics of VE in Cervical Spinal Cord Injury patients. And we analyzed the association of VE, and its evaluation and the prognosis of swallowing function as a result of oral intake at discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral intake at discharge
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From january 1st, 2015 to March 31th, 2023, we recruited cervical spinal cord injury inpatients who were diagnosed dysphagia and both undertook dysphagia rehabilitation and VE.
Key exclusion criteria
Exclusion criteria is as follows; patients whose medical chart data did not filfill all of survey items, patients who did not survive at discharge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ohbayashi |
| Middle name | |
| Last name | Shigeru |
Organization
Saitama Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
350-8550
Address
1981 kamoda,kawagoeshi, saitama, Japan.
TEL
049-228-3686
ohbayash@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Taguchi |
| Middle name | |
| Last name | Kazue |
Organization
Saitama Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
350-8550
Address
1981 kamoda,kawagoeshi, saitama, Japan.
TEL
049-228-3686
Homepage URL
k_tagu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
No organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Boards of Saitama Medical center
Address
1981 kamoda,kawagoeshi, saitama, Japan.
Tel
049-228-3902
smcrinri@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
100
Results
The oral-intake and parenteral-nutrition groups included 35 and 65 participants, respectively. Univariate analysis revealed significant differences in age, length of hospital stay, and Barthel Index (BI) gain between the two groups. FEES revealed that only vallecular residues were significantly greater in the parenteral-nutrition group, with an effect size of 0.24, which was higher than that of other FEES parameters.
Results date posted
| 2024 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Dysphagia is a common secondary complication of cervical spinal-cord injury (CSCI) with an estimated incidence of 22.5-41.0%. A recent scoping review claimed that untreated dysphagia in patients with CSCI may lead to an increase in the length of hospital stay and overall cost of care, and a decrease in patients quality of life. Therefore, precise assessment of dysphagia following CSCI and knowledge of its prognosis are essential for developing a strategy for CSCI rehabilitation. However, studies using FEES to evaluate evaluating dysphagia after CSCI are lacking. Moreover, understanding the long-term prognosis of dysphagia and whether full oral feeding can be achieved after CSCI is important for patients However, the association between the FEES results and the prognosis of patients with CSCI, focusing on oral intake, remains unknown.
Participant flow
This single-center retrospective cohort study included patients with CSCI admitted to an academic medical center between January 2015 and March 2023.
The inclusion criteria were as follows: 1) age more than 16 years; 2) dysphagia confirmed on FEES; 3) adequate cognition to participate; 4) receiving rehabilitation intervention for dysphagia.
The exclusion criteria were as follows: 1) history of strokebrain injury, or brain tumor; 2) neurodegenerative diseases and mental disorders; 3) uncontrolled seizures; 4) disturbed consciousness; 5) history of esophageal, pharyngeal, larynx, or glottic cancer; and 6) severe dysphagia precluding FEES.
Adverse events
There was no adverse events during performing our study.
Outcome measures
sex, the type of residence prior to hospitalization, AIS on admission, neurological motor level, posterior longitudinal ligament ossification, mechanical ventilation, tracheostomy at the time of FEES, tube feeding, ADL before hospitalization, and all FEES parameters, age, length of hospital stay, RSST(Repetitive saliva swallowing test) score, BI on admission, and BI gain.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From January 2015 to March 2023, we recruited participants admitted to an acute university hospital, and who diagnosed dysphagia and undertook speech therapy and VE. This study investigated the detail characteristics of VE in Cervical Spinal Cord Injury patients. And we analyzed the association of VE, its evaluation(Hyodo score) and the prognosis of swallowing function as a result of oral intake at discharge.
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057773
