UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048575 |
|---|---|
| Receipt number | R000047223 |
| Scientific Title | Predictors for Gait Independence in Patients who Underwent Mechanical Ventilation in a Critical Care Center |
| Date of disclosure of the study information | 2022/08/03 |
| Last modified on | 2023/06/10 16:52:23 |
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Basic information
Public title
A survey on the walking status of patients who need ventilator treatment until they are discharged or transferred to another hospital
Acronym
A survey on the walking status of patients who need ventilator treatment until they are discharged or transferred to another hospital
Scientific Title
Predictors for Gait Independence in Patients who Underwent Mechanical Ventilation in a Critical Care Center
Scientific Title:Acronym
Predictors for Gait Independence in Patients who Underwent Mechanical Ventilation in a Critical Care Center
Region
| Japan |
Condition
Condition
critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Predictors affecting gait independence during discharge or transfer of critical ill patients who underwent mechanical ventilation in a critical care center
Basic objectives2
Others
Basic objectives -Others
To clarify the difference in HRQOL between the gait independence and non-independence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Independence rate of gait at transfer/discharge (hazard ratio)
Key secondary outcomes
Comparison of walking independence rate among predictors
Comparison between HRQOL, and depressive symptoms between two groups (gait independent/gait non-independence)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MV management is over 48 hours
Age: 18 years old or older at the time of obtaining consent
Gender: Any
Walkable before hospitalization (including walking aids)
Rehabilitation prescription from doctor
Surgery: Any
Enter the advanced lifesaving emergency center
A person who, after receiving a sufficient explanation before participating in this research, has obtained an informed consent of the research subject or his/her family.
Key exclusion criteria
Leave the Advanced Emergency and Critical Care Center within 72 hours
Cerebrovascular disease
Those who have been on artificial respiration management before admission
In-hospital death
Fractures of the spine, pelvis, and lower limbs that cause lower limb loading
Amputation of upper and lower limbs
Irreversible (or prolonged) consciousness disorder
Spinal cord injury
Malignant tumor and other diseases within 6 months of prognosis
Those who cannot understand the purpose of research and have difficulty communicating
Post-transplantation (due to this hospitalization)
Those who had a walker walk before hospitalization
Any other person whom the researcher judges to be inappropriate as a research target person
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Yoshinaga |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Department of Rehabilitation
Zip code
8568562
Address
2-1001-1 Kubara, Omura-city, Nagasaki
TEL
0957523121
snowboard_atp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7900
Homepage URL
ryokozu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7900
snowboard_atp@yahoo.co.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
| 2022 | Year | 08 | Month | 03 | 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
144
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047223
