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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025255
Receipt No. 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 2019/12/03

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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
Email 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
Email keishii1101@gmail.com

Sponsor
Institute Fukuyama City Hospital
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)

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
Email 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 Main results already published
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
2019 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.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


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