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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034851
Receipt No. R000039738
Scientific Title Therapeutic evaluation of Computed Tomography findings for efficacy of prone ventilation in Acute Respiratory Distress Syndrome patients with abdominal surgery
Date of disclosure of the study information 2018/11/11
Last modified on 2018/11/10

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Basic information
Public title Therapeutic evaluation of Computed Tomography findings for efficacy of prone ventilation in Acute Respiratory Distress Syndrome patients with abdominal surgery
Acronym Therapeutic evaluation of Computed Tomography findings for efficacy of prone ventilation in Acute Respiratory Distress Syndrome patients with abdominal surgery
Scientific Title Therapeutic evaluation of Computed Tomography findings for efficacy of prone ventilation in Acute Respiratory Distress Syndrome patients with abdominal surgery
Scientific Title:Acronym Therapeutic evaluation of Computed Tomography findings for efficacy of prone ventilation in Acute Respiratory Distress Syndrome patients with abdominal surgery
Region
Japan

Condition
Condition ARDS
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the association between computed tomography findings and the efficacy of prone ventilation for patients with ARDS after abdominal surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes weaning from mechanical ventilation
Key secondary outcomes patient characteristics, duration of ICU stay, outcome(28days, 90 days), P/F ratio

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 Participants were patients admitted to the intensive care unit (ICU) in our hospital between 2004 and 2018 who had developed ARDS following surgery for intra-abdominal infection and who had undergone lung CT on admission to the ICU.
Key exclusion criteria 1) Patients with mechanical ventilation management less than 72 hours
2) Pediatric patients under 15 years of age
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroomi Tatsumi
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address South1 West15, Chuo-ku, Sapporo
TEL 011-611-2111
Email tatsumi@qc4.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name MAsayuki Akatsuka
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address South1 West15, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email m_a_let_go@yahoo.co.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 11 Month 11 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
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information Weaning from mechanical ventilation was significantly earlier in the prone group with DLA than in the supine group with DLA. The mortality rate after 28 days and 90 days was significantly lower for the prone group with DLA than for the supine group with DLA.

Management information
Registered date
2018 Year 11 Month 10 Day
Last modified on
2018 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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