UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The retrospective observational study of risk factors for unexpected respiratory exacerbation in traumatic cervical spinal cord injury
Title of the study (Brief title)	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	Azuna Kinoshita
Organization	Wakayama Medical University Hospital
Division name	High Care Unit
Address	811-1 Kimiidera, Wakayama, Wakayama prefecture
TEL	073-447-2300
Email	wpmz00315@nike.eonet.ne.jp

Public contact
Name of contact person	Mika Morishita
Organization	Wakayama Medical University Hospital
Division name	High Care Unit
Address	811-1 Kimiidera, Wakayama, Wakayama prefecture
TEL	073-447-2300
Homepage URL
Email	n1411010@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041008