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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000004395 |
Receipt No. | 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 |
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 |
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Condition | ||||
Condition | Acute lung injury | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | 1) upper gastrointestinal disease
2) acute coronary syndrome 3) neuromuscular disease 4) interstitial pneumonia and lung fibrosis |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Chiba Aoba Municipal Hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005254 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |