UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053546 |
|---|---|
| Receipt number | R000061103 |
| Scientific Title | EIT monitoring on ventilation distribution in patients with multiple rib fracture - A prospective observational study - |
| Date of disclosure of the study information | 2024/02/08 |
| Last modified on | 2024/02/08 11:08:49 |
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Basic information
Public title
EIT monitoring on ventilation distribution in patients with multiple rib fracture - A prospective observational study -
Acronym
EIT monitoring on ventilation distribution in patients with multiple rib fracture - A prospective observational study -
Scientific Title
EIT monitoring on ventilation distribution in patients with multiple rib fracture - A prospective observational study -
Scientific Title:Acronym
EIT monitoring on ventilation distribution in patients with multiple rib fracture - A prospective observational study -
Region
| Japan |
Condition
Condition
Patients with multiple rib fracture
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of a series of treatment courses (nerve block, internal or external fixation) undergone by patients with multiple rib fractures on ventilation distribution and respiratory function.
Basic objectives2
Others
Basic objectives -Others
exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calculate and evaluate using Electrical Impedance Tomography (EIT) the percent change in intrapulmonary ventilation distribution before and after treatment (internal fixation, external fixation, nerve block) performed on patients with multiple rib fractures.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
More than 3 rib fractures on one side
Written consent for participation in the study has been obtained from the individual or a surrogate
Key exclusion criteria
A patient has hypotension requiring high-dose vasopressor administration
A patient with Glasgow Coma Scale<8
Severe trauma to the chest wall, brain, and spinal cord injury.
A patient with Implanted pacemaker
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Matsumoto |
Organization
Shimane university hospital
Division name
Department of Intensive Care Unit
Zip code
693-0024
Address
89-1, Enya-cho, Izumo-shi, Shimane, 693-0024, Japan
TEL
0853-23-2111
keita.ma@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Matsumoto |
Organization
Shimane university hospital
Division name
Department of Intensive care Unit
Zip code
693-0024
Address
89-1, Enya-cho, Izumo-shi, Shimane, 693-0024, Japan
TEL
0853-23-2111
Homepage URL
keita.ma@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane university hospital
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
Shimane University School of Medicine Clinical Research Center
Address
89-1, Enya-cho, Izumo-shi, Shimane, 693-0024, Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2024 | Year | 02 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Exploratory research - A single-center prospective observational study -
Management information
Registered date
| 2024 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061103
