UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004395 |
|---|---|
| Receipt number | R000005254 |
| Scientific Title | Effects of ventilator setting guided by esophageal pressure measurement |
| Date of disclosure of the study information | 2010/10/20 |
| Last modified on | 2017/04/25 10:26:09 |
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Basic information
Public title
Effects of ventilator setting guided by esophageal pressure measurement
Acronym
Effects of ventilator setting guided by esophageal pressure
Scientific Title
Effects of ventilator setting guided by esophageal pressure measurement
Scientific Title:Acronym
Effects of ventilator setting guided by esophageal pressure
Region
| Japan |
Condition
Condition
Acute lung injury
Classification by specialty
| Pneumology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of positive endo-expiratory pressure setting guided by esopageal pressure measurement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Ventilator duration
Key secondary outcomes
Survival rate, P/F ratio, ICU duration, serum cytokine concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A group of patients whose PEEP is set guided by esophageal pressure measurement
Interventions/Control_2
A group of patients whose PEEP is set according to a ventilator management protocol guided by the required fraction of inspired oxygen level
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 18 years of age or older
2) tracheal intubation and ventilator management required for the treatment of acute lung injury
3) written informed consent provided by the patient or his/her family.
Key exclusion criteria
1) upper gastrointestinal disease
2) acute coronary syndrome
3) neuromuscular disease
4) interstitial pneumonia and lung fibrosis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasumasa Morita |
Organization
Chiba Aoba Municipal Hospital
Division name
Department of emergency and critical care medicine
Zip code
Address
1273-2 Aoba-cho, Chuo-ku, Chiba
TEL
+81-43-227-1131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasumasa Morita |
Organization
Chiba Aoba Municipal Hospital
Division name
Department of emergency and critical care medicine
Zip code
Address
1273-2 Aoba-cho, Chuo-ku, Chiba
TEL
+81-43-227-1131
Homepage URL
Sponsor or person
Institute
Chiba Aoba Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba Aoba Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Chiba University Hospital
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
千葉市立青葉病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005254
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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