UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047376 |
|---|---|
| Receipt number | R000054038 |
| Scientific Title | Assessment of sleep status and related factors in the intensive care unit |
| Date of disclosure of the study information | 2022/04/03 |
| Last modified on | 2023/04/04 10:31:23 |
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Basic information
Public title
Assessment of sleep status and related factors in the intensive care unit
Acronym
Assessment of factors related to sleep status in ICU
Scientific Title
Assessment of sleep status and related factors in the intensive care unit
Scientific Title:Acronym
Assessment of factors related to sleep status in ICU
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate how sleep evaluation using the Richard Campbell sleep evaluation sheet changes during the stay in the intensive care unit.
Basic objectives2
Others
Basic objectives -Others
We investigate the relationship between the development of delirium, rehabilitation progression, medications used, online visits, and the course of sleep assessment during the intensive care unit admission.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aim of this study is to investigate how sleep evaluation using the Richard Campbell sleep evaluation sheet changes during the stay in the intensive care unit.
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
Patients who are 18 years old or older and entering the intensive care unit
Patients who are expected to enter the ICU for a long period of time (generally 48 hours: a period during which three or more sleep surveys can be conducted)
Patients who can be evaluated sleep by the Richard Campbell Sleep Questionnaire
Route of admission does not matter, such as scheduled surgery, emergency surgery, or sudden changes in the hospital
Key exclusion criteria
Patients under 18 years old
Patients who enter the ICU for a short period of time (patients who leave the room within 48 hours or have a sleep evaluation of fewer than 3 times)
Patients who declined to participate in the research
Patients who have difficulty in conducting a sleep survey using the Richard Campbell sleep questionnaire: impaired consciousness, deep sedation, etc. However, it is not excluded when the state of consciousness improves.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Ishii |
Organization
Fukuyama City Hospital
Division name
Department of Anesthesiology, Intensive Care Unit
Zip code
721-8511
Address
Zao-cho 5-23-1, Fukuyama, Hiroshima, Japan
TEL
0849415151
keishii1101@gmail.com
Public contact
Name of contact person
| 1st name | Kenzo |
| Middle name | |
| Last name | Ishii |
Organization
Fukuyama City Hospital
Division name
Department of Anesthesiology, Intensive Care Unit
Zip code
721-8511
Address
Zao-cho 5-23-1, Fukuyama, Hiroshima, Japan
TEL
0849415151
Homepage URL
keishii1101@gmail.com
Sponsor or person
Institute
Fukuyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuyama City Hospital
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
Fukuyama City Hospital
Address
Zao-cho 5-23-1, Fukuyama, Hiroshima, Japan
Tel
0849415151
shimin-byouin@city.fukuyama.hiroshima.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 | 04 | 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
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
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054038
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
