UMIN-CTR Clinical Trial

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
Email

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
Email

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
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	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
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

Contact us.