UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023144 |
|---|---|
| Receipt number | 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 | 2021/01/04 00:03:33 |
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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
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
nann_5115@ybb.ne.jp
Sponsor or person
Institute
Gifu City Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026681
