UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044965 |
|---|---|
| Receipt number | R000051376 |
| Scientific Title | Early mobilisation of critically ill patients using a mobile lift. |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2024/02/07 12:18:45 |
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Basic information
Public title
Early mobilisation of critically ill patients using a mobile lift.
Acronym
Early mobilisation of ICU patients using a mobile lift.
Scientific Title
Early mobilisation of critically ill patients using a mobile lift.
Scientific Title:Acronym
Early mobilisation of ICU patients using a mobile lift.
Region
| Japan |
Condition
Condition
Critical illness
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of mobile lift on early mobilisation in critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Days to 4 or more in the ICU mobility sclae.
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 addition to the conventional rehabilitation, using a mobile lift in the intervention group.
Interventions/Control_2
Perform conventional rehabilitation in the control group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are able to walk independently before ICU admission and expected to require mechanical ventilation for at least 48 hours.
Key exclusion criteria
Prohibition of load exercise, neuromuscular disease, weight 200 kg or more, after cardiopulmonary arrest, cerebral organic disease, convulsions, epilepsy, transfer after 48 hours or more of ventilator management,COVID-19
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | Ginga |
| Middle name | |
| Last name | Suzuki |
Organization
Toho University Omori Medical Center
Division name
Critical Care Center
Zip code
143-8541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
0337624151
ginga.suzuki@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Ginga |
| Middle name | |
| Last name | Suzuki |
Organization
Toho University Omori Medical Center
Division name
Critical Care Center
Zip code
143-8541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
0337624151
Homepage URL
ginga.suzuki@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding.
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
Toho University Omori Medical Center Ethics Committee
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
Tel
0337624151
omori.rinri@ext.toho-u.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
| 2021 | Year | 07 | Month | 30 | 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
92
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
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD sharing Plan description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | 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 | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051376
