UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036048 |
|---|---|
| Receipt number | R000041008 |
| Scientific Title | The retrospective observational study of risk factors for unexpected respiratory exacerbation in traumatic cervical spinal cord injury |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2019/02/28 17:48:44 |
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Basic information
Public title
The retrospective observational study of risk factors for unexpected respiratory exacerbation in traumatic cervical spinal cord injury
Acronym
Predictors for respiratory exacerbation in traumatic cervical spinal cord injury
Scientific Title
The retrospective observational study of risk factors for unexpected respiratory exacerbation in traumatic cervical spinal cord injury
Scientific Title:Acronym
Predictors for respiratory exacerbation in traumatic cervical spinal cord injury
Region
| Japan |
Condition
Condition
Traumatic cervical spinal cord injury
Classification by specialty
| Orthopedics | Emergency medicine | Intensive care medicine |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find risk factors associated with unexpected respiratory exacerbation in traumatic cervical spinal cord injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
excessive airway secretion
Key secondary outcomes
Injury severity score, Spinal injury level, Hospitalization, ICU stay, Ventilator days
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
Hospitalized patients with traumatic cervical spinal cord injury in medical emergency center of Wakayama Medical University from January 2013 to December 2017
Key exclusion criteria
Central spinal cord injury, No magnetic resonance imaging, Unknown spinal injury level, Cardiopulmonary arrest on arrival, Brain death, Injury severity score >= 41, Initial diagnosis of orthopedist
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Azuna Kinoshita |
Organization
Wakayama Medical University Hospital
Division name
High Care Unit
Zip code
Address
811-1 Kimiidera, Wakayama, Wakayama prefecture
TEL
073-447-2300
wpmz00315@nike.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Morishita |
Organization
Wakayama Medical University Hospital
Division name
High Care Unit
Zip code
Address
811-1 Kimiidera, Wakayama, Wakayama prefecture
TEL
073-447-2300
Homepage URL
n1411010@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2019 | Year | 03 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041008
