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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023144
Receipt No. R000026681
Scientific Title Observational study of the hemodynamic effect of PEEP during mechanical ventilation.
Date of disclosure of the study information 2016/07/13
Last modified on 2019/07/16

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Basic information
Public title Observational study of the hemodynamic effect of PEEP during mechanical ventilation.
Acronym Observational study of the hemodynamic effect of PEEP.
Scientific Title Observational study of the hemodynamic effect of PEEP during mechanical ventilation.
Scientific Title:Acronym Observational study of the hemodynamic effect of PEEP.
Region
Japan

Condition
Condition Mechanically ventilated patients.
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hemodynamic effect of PEEP on mechanically ventilated patients is not understood well. We observe the hemodynamic effect of PEEP using trans thoracic echocardiography.
Basic objectives2 Others
Basic objectives -Others Measuring Pes and Ea at the time of each level of PEEP.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pes and Ea.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Apllying the following level of PEEP; 0, 5, 10, and 15mmHg
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Mechanicall ventilated patients with informed conscent.
Key exclusion criteria Patients with atrial fibrillation, renal replacement therapy, or extracorporeal circulation.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Kimito
Middle name
Last name Minami
Organization Gifu City Hospital
Division name Department of anesthesiology
Zip code 500-8513
Address Kashima 7-1, Gifu, Gifu, Japan
TEL +81-58-251-1101
Email nann_5115@ybb.ne.jp

Public contact
Name of contact person
1st name Kimito
Middle name
Last name Minami
Organization Gifu City Hospital
Division name Department of anesthesiology
Zip code 500-8513
Address Kashima 7-1, Gifu, Gifu, Japan
TEL +81-58-251-1101
Homepage URL
Email nann_5115@ybb.ne.jp

Sponsor
Institute Gifu City Hospital
Institute
Department

Funding Source
Organization Gifu City Hospital
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 Gifu City Hospital
Address Kashima 7-1, Gifu, Gifu, Japan
Tel +81-58-251-1101
Email nann_5115@ybb.ne.jp

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
2016 Year 07 Month 13 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 100
Results
not yet
Results date posted
2019 Year 07 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
not yet
Participant flow
not yet
Adverse events
not yet
Outcome measures
not yet
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 06 Month 03 Day
Date of IRB
2016 Year 07 Month 01 Day
Anticipated trial start date
2016 Year 07 Month 13 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 13 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026681

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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