UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025255 |
|---|---|
| Receipt number | R000029031 |
| Scientific Title | Relationship between a high-inspired oxygen concentration and gravity-dependent atelectasis in trauma patients |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2020/09/19 13:00:20 |
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Basic information
Public title
Relationship between a high-inspired oxygen concentration and gravity-dependent atelectasis in trauma patients
Acronym
Oxygen concentration and atelectasis in trauma patients
Scientific Title
Relationship between a high-inspired oxygen concentration and gravity-dependent atelectasis in trauma patients
Scientific Title:Acronym
Oxygen concentration and atelectasis in trauma patients
Region
| Japan |
Condition
Condition
High-energy trauma patients
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze the relationship between a high-inspired oxygen concentration and gravity-dependent atelectasis formation in high-energy trauma patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of gravity-dependent atelectasis in the first 48 hours for high-energy trauma patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In this study, high-energy trauma patients who are transported and admitted to our emergency department and have received at least two computed tomography (CT) scans are included.
Key exclusion criteria
We exclude patients who do not receive two CT scans, who die within 24 hours from injury, and who are not categorized as having high-energy trauma
Target sample size
1000
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
5-23-1 Zao-cho, Fukuyama City, Hiroshima, Japan, 721-8511
TEL
084-841-5151
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
5-23-1 Zao-cho, Fukuyama City, Hiroshima, Japan, 721-8511
TEL
084-841-5151
Homepage URL
keishii1101@gmail.com
Sponsor or person
Institute
Fukuyama City Hospital
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
IRB, Fukuyama City Hospital
Address
5-23-1 Zao-cho, Fukuyama City, Hiroshima, Japan, 721-8511
Tel
084-841-5151
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
福山市民病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
Accepted but Unpublished
Publication of results
Published
Result
URL related to results and publications
Accepted but Unpublished
Number of participants that the trial has enrolled
911
Results
A univariate analysis showed that the rate of the high-inspired oxygen concentration in the atelectasis group was significantly higher than that in the non-atelectasis group (43.4% vs. 30.1%, p <0.001) .However, a logistic regression analysis showed that that there was no significant relationship between the oxygen concentration and the formation of dorsal atelectasis (OR: 1.197, 95% CI: 0.852-1.683, p = 0.30).
Results date posted
| 2019 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We performed a retrospective cohort study of 911 high-energy trauma patients who underwent chest CT scans at least twice after admission.
Four hundred sixty-five patients (51.0%) developed atelectasis according to the second CT scan, and 338 (37.1%) received a high-inspired oxygen concentration.
Participant flow
This study is a retrospective cohort study.
Adverse events
None
Outcome measures
The study's primary outcome was dorsal atelectasis formation diagnosed based on CT images.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 12 | 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
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2020 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029031
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/12/13 | Dataset; Oxygen Concentration and atelectasis in trauma patients.xlsx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/12/13 | Dataset; Oxygen Concentration and atelectasis in trauma patients.xlsx |
