UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033980 |
|---|---|
| Receipt number | R000038623 |
| Scientific Title | Effect of mechanical sputum assistance for ventilated patients in intensive care unit |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2020/05/25 22:20:07 |
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Basic information
Public title
Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Acronym
Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Scientific Title
Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Scientific Title:Acronym
Effect of mechanical sputum assistance for ventilated patients in intensive care unit
Region
| Japan |
Condition
Condition
Ventilated patients in the intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of Mechanical Insufflator-Exsufflator (MI-E) for ventilated patients in the intensive care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of ventilatorv days
Number of ICU days
Key secondary outcomes
rate of reintubatiorn
rate of tracheotomy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use MI-E for 10 times at 40 cmH2O for ventilated patietns
Interventions/Control_2
ICU patients who received standard care only
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
ICU patients who required ventilation for at least 24h and expected for 48h
ICU patients who require lung physical therapy for exsufflation of sputum
Key exclusion criteria
Patients whom principal investigators judge to be inappropriate for examinee.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensuke Nakamura |
Organization
Hitachi General Hospital
Division name
Department of emergency andi intensive care medicine
Zip code
Address
2-1-1, Jonancho, Hitachi city, Ibaraki prefecture
TEL
0294-23-1111
kensuke.nakamura.oz@hitachi.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Nakamura |
Organization
Hittachi Gerneral Hospital
Division name
Department of emergency and intensive care medicine
Zip code
Address
2-1-1, Jonancho, Hitachi city, Ibaraki prefecture
TEL
0294-23-1111
Homepage URL
kensuke.nakamura.oz@hitachi.com
Sponsor or person
Institute
Hittachi Gerneral Hospital
Institute
Department
Personal name
Funding Source
Organization
Hittachi Gerneral Hospital
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
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 | 09 | 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
38
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
| 2017 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2018 | Year | 09 | Month | 01 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038623
