UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040207 |
|---|---|
| Receipt number | R000045855 |
| Scientific Title | Effect of muscle relaxant on distribution of ventilation and aeration in patients with acute respiratory failure. |
| Date of disclosure of the study information | 2020/04/21 |
| Last modified on | 2020/04/21 05:52:29 |
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Basic information
Public title
Effect of muscle relaxant on distribution of ventilation and aeration in patients with acute respiratory failure.
Acronym
EIT monitoring before and after administration of muscle relaxant
Scientific Title
Effect of muscle relaxant on distribution of ventilation and aeration in patients with acute respiratory failure.
Scientific Title:Acronym
EIT monitoring before and after administration of muscle relaxant
Region
| Japan |
Condition
Condition
respiratory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effect of muscle relaxant on distribution of ventilation and aeration in patients with strong inspiratory effort using electrical impedance tomography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in end-expiratory lung impedance before and after administration of muscle relaxant
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)mechanically ventilated patients with strong spontaneous breath
2)age 20<=, <=85
3)admission on ICU
4)written informed consent
Key exclusion criteria
1)no allergy for muscle relaxant
2)patients with accelerated respiratory drive due to central nerve impairment
3)haemodynamic instability with mean arterial pressure less than 55 mmHg
4) insuitable for EIT belt placement
5)heart beat supported by pacemaker
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Shono |
Organization
Showa university
Division name
Intensive care medicine
Zip code
142-8666
Address
Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL
03-3784-8575
atsukos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Shono |
Organization
Showa university
Division name
Intensive care medicine
Zip code
142-8666
Address
Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL
03-3784-8575
Homepage URL
atsukos@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board
Address
Hantanodai1-5-9, Shinagawa, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2020 | Year | 04 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
monitor the distribution of ventilation and aeration before and after administration of muscle relaxant using electrical impedance tomography in patients with strong inspiratory effort
Management information
Registered date
| 2020 | Year | 04 | Month | 21 | Day |
Last modified on
| 2020 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045855
