UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012155 |
|---|---|
| Receipt number | R000013814 |
| Scientific Title | Pressure -Volume curves and Ratio of dead space to tidal volume in Patients with Extracorporeal membrane oxygenation. |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2017/05/02 20:45:55 |
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Basic information
Public title
Pressure -Volume curves and Ratio of dead space to tidal volume in Patients with Extracorporeal membrane oxygenation.
Acronym
Pressure -Volume curves and Ratio of dead space to tidal volume in Patients with Extracorporeal membrane oxygenation.
Scientific Title
Pressure -Volume curves and Ratio of dead space to tidal volume in Patients with Extracorporeal membrane oxygenation.
Scientific Title:Acronym
Pressure -Volume curves and Ratio of dead space to tidal volume in Patients with Extracorporeal membrane oxygenation.
Region
| Japan |
Condition
Condition
Respiratory insufficiency
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure P-V curve and Ratio of dead space to tidal volume in patients with Extracorporeal Membrane Oxygenation.
Basic objectives2
Others
Basic objectives -Others
Analyze the correlation between P-V curve and ECMO removal.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the number of days until ECMO removal
Key secondary outcomes
static compliance,LIP;lower inflection point, UIP;upper inflection point,Hysteresis,Recruitment volume,
Ratio of dead space to tidal volume,Blood gas
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of Pressure Volume curve
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
Patient with Extracorporeal Membrane Oxygenation will be included .
Key exclusion criteria
increased intracranial pressure, Pneumothorax, severe hemodynamic instability, expected to be dead in 48 hours
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Uji |
Organization
Osaka University
Division name
Department of Anesthesiology & Intensive Care Medicine.
Zip code
Address
2-15, Yamadaoka, Suita-city, Osaka
TEL
06-6879-5820
makiko.uj@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Uji |
Organization
Osaka University
Division name
Intensive Care Unit
Zip code
Address
2-15, Yamadaoka, Suita-city, Osaka
TEL
06-6879-5820
Homepage URL
makiko.uj@gmail.com
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
大阪大学医学部附属病院(大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | 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
| 2013 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013814
