UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034851 |
|---|---|
| Receipt number | 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 15:34:00 |
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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
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
m_a_let_go@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039738
