UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047449 |
|---|---|
| Receipt number | R000054108 |
| Scientific Title | evaluation of ventilation distribution during stepwise recruitment maneuver and decremental PEEP trial using electrical impedance tomography |
| Date of disclosure of the study information | 2022/04/09 |
| Last modified on | 2022/04/09 20:05:48 |
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Basic information
Public title
evaluation of ventilation distribution during stepwise recruitment maneuver and decremental PEEP trial using electrical impedance tomography
Acronym
Optimal PEEP selected by SRM and EIT
Scientific Title
evaluation of ventilation distribution during stepwise recruitment maneuver and decremental PEEP trial using electrical impedance tomography
Scientific Title:Acronym
Optimal PEEP selected by SRM and EIT
Region
| Japan |
Condition
Condition
mechanically ventilated patients with respiratory failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare optimal PEEP levels selected by different methods using best compliance detected by SRM (automatically performed function of recruitment maneuver installed in Servo-U ventilator)and EIT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Optimal PEEP level selected by SRM (automatically performed function of recruitment maneuver installed in Servo-U ventilator)
Key secondary outcomes
Optimal PEEP level selected by EIT
Ventilation distribution
Respiratory parameters
Blood gas analysis
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)patients with respiratory failure
2)Age>=20, <=85
3)admitted in ICU
4)written informed consent
Key exclusion criteria
1)no indication of mechanical ventilation
2)hemodynamically unstable with mean blood pressure less than 55 mmHg
3)Not suitable for EIT attachment
4)patients with medical history of pneumothorax
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Somei |
Organization
Showa University
Division name
Intensive care medicine
Zip code
142-8666
Address
Hantanodai1-5-9, Shinagawa, Tokyo, Japan
TEL
03-3784-8575
some_papaiya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Somei |
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
some_papaiya@yahoo.co.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
Showa University Research Ethics Review Board
Address
Hatanodai1-5-8, 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
| 2022 | Year | 04 | Month | 09 | 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 | 08 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 11 | 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
Stepwise recruitment maneuver followed by PEEP titration is performed using Servo-U ventilator automatically. Evaluate ventilation distribution and select optimal PEEP level with best compliance, which is compared to the optimal PEEP level detected by EIT
Management information
Registered date
| 2022 | Year | 04 | Month | 09 | Day |
Last modified on
| 2022 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054108
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
