UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046443 |
|---|---|
| Receipt number | R000052992 |
| Scientific Title | Evaluation of the usefulness of a swallowing electrical stimulator in maintaining swallowing function in patients after extubation: a randomized controlled trial |
| Date of disclosure of the study information | 2022/01/04 |
| Last modified on | 2022/09/08 15:06:41 |
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Basic information
Public title
Evaluation of the usefulness of a swallowing electrical stimulator in maintaining swallowing function in patients after extubation: a randomized controlled trial
Acronym
Evaluation of the usefulness of a swallowing electrical stimulator in maintaining swallowing function in patients after extubation: a randomized controlled trial
Scientific Title
Evaluation of the usefulness of a swallowing electrical stimulator in maintaining swallowing function in patients after extubation: a randomized controlled trial
Scientific Title:Acronym
Evaluation of the usefulness of a swallowing electrical stimulator in maintaining swallowing function in patients after extubation: a randomized controlled trial
Region
| Japan |
Condition
Condition
post-extubation dysphagia(PED)
Classification by specialty
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the hypothesis that swallowing rehabilitation with NMES (neuromuscular electrical stimulation) is more effective than regular rehabilitation alone in improving swallowing function in patients with PED.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FOIS (functional oral intake scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the NMES group, in addition to the usual swallowing rehabilitation (tongue exercise, TTS: thermal-tactile stimulation [cold pressure stimulation], Mendelsohn maneuver), NEMS will be attached to the mandible and swallowing rehabilitation will be performed. Interventions for both groups will be 30 minutes per session, 5 times per week. In the NMES group, the upper limit of the frequency that is not painful to the patient will be used, and stimulation will be repeated for 5 seconds followed by 15 seconds of rest (3 sessions per minute, 90 sessions in total). In the NMES group, patients will be stimulated for 5 seconds at the upper limit of non-painful frequency, followed by 15 seconds of rest (3 sessions per minute, total 90 sessions per session).
Interventions/Control_2
Only normal rehabilitation is performed, and the same observation and evaluation as in the intervention group is performed.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patient is in the intensive care unit of Hitachi General Hospital.
2) Age over 20 years at the time of obtaining consent
3) The patient who has been extubated after tracheal intubation
4) The patient who is able to perform swallowing movements but has swallowing dysfunction (FOIS 1-5)
5) The patient has been fully explained about the research, and written consent of his/her own or his/her representative's free will has been obtained with sufficient understanding
Key exclusion criteria
1) Patients who have not taken orally prior to ICU admission (FOIS 2 or lesser)
2) After implantation of artificial heart or pacemaker
3) Gastric banding (PEG) or percutaneous transesophageal gastric tube (PTEG) installation
4) After tracheostomy
5) After head and neck or esophageal surgery
6) Anatomical problem or infection in the mandible that prevents the application of the electrode
7) Disorders of consciousness due to severe head trauma (GCS 13 or lesser)
8) Cognitive dysfunction with MMSE 21 or lesser
9) Patients who have already been included in this study
10) Informed consent could not be obtained
11) Patients deemed unsuitable as subjects by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Takahashi |
Organization
Hitachi general hospital
Division name
Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1, johnancho, Hitachi, Ibaraki, Japan
TEL
0294231111
yuji.mail@me.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Takahashi |
Organization
Hitachi general hospital
Division name
Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1, Johnancho, Hitachi, Ibaraki, Japan
TEL
0294231111
Homepage URL
yuji.mail@me.com
Sponsor or person
Institute
Hitachi general hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of corporative hospital group
Address
2-1-1, Johnancho, Hitachi, Ibaraki, Japan
Tel
0294231111
yuji.mail@me.com
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
| 2022 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052992
