UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040319 |
|---|---|
| Receipt number | R000046003 |
| Scientific Title | An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit |
| Date of disclosure of the study information | 2020/05/07 |
| Last modified on | 2020/08/27 14:30:24 |
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Basic information
Public title
An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Acronym
An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Scientific Title
An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Scientific Title:Acronym
An observational study to determine the risk factor for unplanned extubation or removal of catheter in the intensive care unit
Region
| Japan |
Condition
Condition
Mechanically ventilated patients
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the risk factor of risk events.
Basic objectives2
Others
Basic objectives -Others
To evaluate Intentional movements, CAM-ICU, RASS, BPS, and days after ICU admission as risk factors of risk events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence and frequency of risk and the frequency of intentional movements
Key secondary outcomes
The incidence and frequency of risk and CAM-ICU, RASS, BPS, days after ICU admission
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mechanically ill patients managed by analgesia and sedation protcol
Key exclusion criteria
We excluded patients whose RASS is more than or equal to 3.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima university hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-8503
Address
Tokushima
TEL
0886339347
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima university hospital
Division name
Emergency and Critical Care Medicine
Zip code
770-0037
Address
2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL
08016010115
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
The university of Tokushima
Institute
Department
Personal name
Funding Source
Organization
The university of Tokushima
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
Tokushima university hospital, ethics committee in nursing department
Address
2-50-1, Kuramoto, Tokushima 770-8503, Japan
Tel
088-631-3111
awachiken@tokushima-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
| 2020 | Year | 05 | Month | 07 | 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
82
Results
Of the 82 patients enrolled, upper limb movements were observed in 49 (60%) patients with risk behaviors in 15 (18%) patients (Fig. 1a). There were 331 total movements with 27 (8%) risk movements such as grabbing the intubation tube (n=26) or catheter (n=1). No-risk movements were classified into reaction (n=268; 81%), expression (n=16; 5%), and activity (n=20; 6%).
Results date posted
| 2020 | Year | 08 | Month | 27 | Day |
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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study: Evaluation of risk factors for risk events in mechanically ventilated patients.
Management information
Registered date
| 2020 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046003
| 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 |
