UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047578 |
|---|---|
| Receipt number | R000054256 |
| Scientific Title | Investigating physical activity of mechanical ventilation patients in the ICU |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/04/25 11:25:55 |
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Basic information
Public title
Investigating physical activity of mechanical ventilation patients in the ICU
Acronym
IPAM study
Scientific Title
Investigating physical activity of mechanical ventilation patients in the ICU
Scientific Title:Acronym
IPAM study
Region
| Japan |
Condition
Condition
Critical ill patient/Mechanically ventilated patinet
Classification by specialty
| Emergency medicine | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
How the physical activity of mechanicai ventilator patients in the ICU affects ADL independence at discharge
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel Index at hospital discharge
Key secondary outcomes
In-hospital mortality, discharge to home, muscle strength (Medical Research Council score; MRC score), length of stay, length of mechanical ventilation, length of stay in ICU, intensity of rehabilitation, timing, intervention time
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
who used mechanically ventilation in the ICU for more than 48 hours were included at the time of ICU admission
Key exclusion criteria
Age 18 years or more
Patients whose hospitalization causing disease is COVID 19
Neurological complications
Lack of communication skills because of disease
Unable to walk indecently before hospitalization
Termina or end of life care
Cases in which getting out of bed is expected to be restricted for a long period of time due to unstable multiple fractures associated with severe trauma
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Gifu University of Health science
Division name
Faculty of Rehabilitation
Zip code
500-8281
Address
Higashiuzura 2-92, Gifu, Gifu, Japan
TEL
058-274-5001
s-watanabe@gifuhoken.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Gifu University of Health science
Division name
Faculty of Rehabilitation
Zip code
500-8281
Address
Higashiuzura 2-92, Gifu, Gifu, Japan
TEL
058-274-5001
Homepage URL
s-watanabe@gifuhoken.ac.jp
Sponsor or person
Institute
Gifu University of Health science
Institute
Department
Personal name
Funding Source
Organization
Gifu University of Health science
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
Gifu University of Health science
Address
Higashiuzura 2-92, Gifu, Gifu, Japan
Tel
058-274-5001
s-watanabe@gifuhoken.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
| 2022 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 30 | Day |
Other
Other related information
(Basic information)
Age, male, height, weight, admission route, Charson Index, presence or absence of dialysis, main cause of ICU admission, sepsis, diabetes, Acute physiology and chronic health evaluation, Sequential organ failure assessment, Drug use at ICU, Extracorporeal membrane oxygenation: With or without
(Rehabilitation information during ICU admission)
Assessment of respiration during rehabilitation: use of mechanical ventilator, oral intubation, tracheotomy.
Assessment of circulation during rehabilitation: use of catecholamine, DOA, DOB, NAD, Epinephrine, Vasopressin.
Assessment of consciousness delirium during rehabilitation
With or without the use of persistent analgesics and sedatives, with pain just before rehabilitation, incidence of delirium.
Other items during rehabilitation: Enteral feeding tube, chest tube, abdominal tube, urine balloon, arterial line, central venous line, presence of drip in inguinal region
Releasing related items in ICU: highest movement level in rehabilitation, nurses participating in rehabilitation, physician, physiotherapist, number of other occupations, ICU mobility scale; achieving IMS Level 3 or higher, IMS Level 3 or higher Cause that was not
Non-rehabilitation interventions in ICU: ABCEDFGHI Bundle.
Adverse events during rehabilitation
(Patient outcome information)
Length of Hospital days, length of ICU days, duration of ventilator, early mobilization related items, Discharge at Barthel Index, Discharge at Medical Research Council sum-score, Discharge at hospital hand grip strength
Management information
Registered date
| 2022 | Year | 04 | Month | 24 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054256
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
