UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033533 |
|---|---|
| Receipt number | R000038238 |
| Scientific Title | Patient-ventilator asynchrony association on diaphragm weakness in patients with acute respiratory failure |
| Date of disclosure of the study information | 2018/08/31 |
| Last modified on | 2021/01/27 09:50:50 |
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Basic information
Public title
Patient-ventilator asynchrony association on diaphragm weakness in patients with acute respiratory failure
Acronym
Patient-ventilator asynchrony and diaphragm weakness
Scientific Title
Patient-ventilator asynchrony association on diaphragm weakness in patients with acute respiratory failure
Scientific Title:Acronym
Patient-ventilator asynchrony and diaphragm weakness
Region
| Japan |
Condition
Condition
Acute respiratory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if early stage patient-ventilator asynchrony affects on diaphragm atrphy in patients with acute respiratory failure
Basic objectives2
Others
Basic objectives -Others
To investigate if excessive respiratory efforts associates with diaphragm atrophy in patients with acute respiratory failure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum change in diaphragm thickness during mechanical ventilation
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
Acute respiratory failure patients with PaO2/FIO2 ratio less than 300 mmHg supposed to be mechanically ventilated for more than 48 hours under assist-controlled ventilation
Key exclusion criteria
Diaphragm dysfunction, neuromuscular disease, pneumothorax, pneumomediastinum, esophageal varix, previous esophageal operation, pregnancy, person without written consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Itagaki |
Organization
Tokushima University Graduate School
Division name
Emergency and Critical Care Medicine
Zip code
7708503
Address
3-18-15 Kuramoto-cho Tokushima 770-8503 JAPAN
TEL
+81-88-633-9347
taiga@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Itagaki |
Organization
Tokushima University Graduate School
Division name
Emergency and Critical Care Medicine
Zip code
7708503
Address
3-18-15 Kuramoto-cho Tokushima 770-8503 JAPAN
TEL
+81-88-633-9347
Homepage URL
taiga@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Departmental
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
Tokushima University Hospital
Address
2-50-1, Kuramoto, Tokushima, Japan
Tel
+81-88-633-9294
awachiken@tokushima-u.ac.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
| 2018 | Year | 08 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The major observation is the association between asynchrony index until 3rd day of mechanical ventilation maximum change in diaphragm thickness during mechanical ventilation.
Management information
Registered date
| 2018 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038238
