UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032944 |
|---|---|
| Receipt number | R000037560 |
| Scientific Title | Influence of mandatory ventilation ratio on diaphragm weakness in critically ill patients |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2019/06/11 10:15:38 |
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Basic information
Public title
Influence of mandatory ventilation ratio on diaphragm weakness in critically ill patients
Acronym
Mandatory ventilation on diaphragm function
Scientific Title
Influence of mandatory ventilation ratio on diaphragm weakness in critically ill patients
Scientific Title:Acronym
Mandatory ventilation on diaphragm function
Region
| Japan |
Condition
Condition
Mechanically ventilated patients in ICU
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if mandatory ventilation ratio during assist/control ventilation influences on diaphragmatic function and atrophy in ICU patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diaphragm thickning fraction 14 days after the start of mechanical ventilation or the day of extubation.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients supposed to be ventilated on asisst-control ventilation for longer than 48 hours in the intensive care unit.
Key exclusion criteria
diaphragmatic dysfunction, history of neuromuscular disease, pneumothorax, pneumomediastinum
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiga Itagaki |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care medicine
Zip code
Address
3-18-15 Kuramotocho, Tokushima 770-8503
TEL
+81-88-633-9347
taiga@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Itagaki |
Organization
Tokushima University Hospital
Division name
Emergency and Critical Care medicine
Zip code
Address
3-18-15 Kuramotocho, Tokushima 770-8503
TEL
+81-88-633-9347
Homepage URL
taiga@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
NONE
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 18 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If respiratory rate measured by the ventilator (RRpt, /min) is equal to set respiratory rate (RRset, /min), we define the minute "mandatory-ventilated minute". We calculate mandatory ventilation ratio for the period from the start of mechanical ventilation to the measurement of diaphragm function, and investigate the relationship between the ratio and morphological and functional changes in diaphragm.
Management information
Registered date
| 2018 | Year | 06 | Month | 11 | Day |
Last modified on
| 2019 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037560
