UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040749 |
|---|---|
| Receipt number | R000046524 |
| Scientific Title | Relationship between cerebral oxygenation response and vital signs at the time of first leaving bed in critically ill patients |
| Date of disclosure of the study information | 2020/06/13 |
| Last modified on | 2024/12/17 20:56:32 |
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Basic information
Public title
Relationship between cerebral oxygenation reaction and vital signs at the time of first leaving bed in critically ill patients
Acronym
Relationship between cerebral oxygenation reaction and vital signs in critically ill patients
Scientific Title
Relationship between cerebral oxygenation response and vital signs at the time of first leaving bed in critically ill patients
Scientific Title:Acronym
Relationship between cerebral oxygenation reaction and vital signs in critically ill patients
Region
| Japan |
Condition
Condition
Critically ill patients admitted to the Emergency and Trauma Center
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between changes in cerebral oxygenation response and outcome and other risk management indices in postural changes during initial mobilization in critically ill patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome, Cerebral oxygenation during postural changes(Bed up position, sitting position)
Key secondary outcomes
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
1. Patients who are admitted to a critical care/trauma center and undergo rehabilitation
2. Patients whose doctors decide to start bed based on clinical criteria
3. Patients who leave their bed for the first time while being admitted to a critical care/trauma center
4. Those who have obtained consent to participate in the research from the person or family in advance
Key exclusion criteria
1. Patients with body mass index over 35 kg/m2
2. NIRS probe not applicable
3. Cases of giving up active treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Imai |
Organization
Uonuma kikan hospital
Division name
Department of Rehabilitation Medicine
Zip code
949-7302
Address
4132 Urasa, Minami Uonuma-shi, Niigata, Japan
TEL
025-777-3200
imaryo1105@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Imai |
Organization
Uonuma kikan hospital
Division name
Department of Rehabilitation Medicine
Zip code
949-7302
Address
4132 Urasa, Minami Uonuma-shi, Niigata, Japan
TEL
025-777-3200
Homepage URL
imaryo1105@gmail.com
Sponsor or person
Institute
Uonuma kikan hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare Applying
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
Uonuma kikan hospital Ethics Committee
Address
4132 Urasa, Minami Uonuma-shi, Niigata, Japan
Tel
025-777-3200
rehabilitation@ncmi.or.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
魚沼基幹病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 13 | 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
Suspended
Date of protocol fixation
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cerebral oxygenation response (local cerebral oxygen saturation, oxygenated hemoglobin change, deoxygenated hemoglobin change, total hemoglobin change) is considered to correlate with vital signs in healthy subjects, and the disease state management and prognosis prediction of critically ill patients It is said to be useful for.
Management information
Registered date
| 2020 | Year | 06 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046524
