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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033980 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Ventilated patients in the intensive care unit | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 |
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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 | |
Institute | Hittachi Gerneral Hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038623 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |