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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000039013 |
Receipt No. | R000044238 |
Scientific Title | Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness. |
Date of disclosure of the study information | 2020/01/01 |
Last modified on | 2020/06/26 |
Basic information | ||
Public title | Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness. | |
Acronym | Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness. | |
Scientific Title | Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness. | |
Scientific Title:Acronym | Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness. | |
Region |
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Condition | ||||
Condition | ICU-acquired weakness | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect of neuromuscular electrical stimulation for preventing ICU-acquired weakness in mechanically ventilated patients. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Daily neuromuscular electrical stimulation knee extension torque |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | For the NMES group,
Patients starts NMES therapy to bilateral knee extension muscles (5min/day, 50Hz, input<100mA, pulse amplitude 600 micro sec, 2 sec on-4sec off in 48 hours after admitting to ICU, Interventions continue everyday while patients use ventilator On the first day and the final day in intervention, |
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Interventions/Control_2 | For plasebo group
No electronic stimulation therapy On the first day and final day of intervention, in placebo group |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | patients who can start NMES therapy in 48hr after admitting to ICU, and continue it more than 2 days
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Key exclusion criteria | under 18 years old, pregnant, BMI over 35, neuromuscular disease patients, Patients who have PM, clinical brain-dead patients, those who can't put electrode on their thigh, etc | |||
Target sample size | 54 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sapporo medical university | ||||||
Division name | Emergency Medicine | ||||||
Zip code | 0608543 | ||||||
Address | 291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan | ||||||
TEL | 011-611-2111 | ||||||
enarimat@sapmed.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Sapporo medical university | ||||||
Division name | Emergency Medicine | ||||||
Zip code | 0608543 | ||||||
Address | 291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan | ||||||
TEL | 011-611-2111 | ||||||
Homepage URL | https://web.sapmed.ac.jp/tccm/index.html | ||||||
yoichikata@gmail.com |
Sponsor | |
Institute | Sapporo medical university |
Institute | |
Department |
Funding Source | |
Organization | Japan Science and Technology Agency |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Sapporo medical university |
Address | 291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan |
Tel | 011-611-2111 |
ji-rskk@sapmed.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 | 札幌医科大学附属病院救命救急センター |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044238 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |