UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048920 |
|---|---|
| Receipt number | R000055710 |
| Scientific Title | Analysis of causes of prolonged ventilatory management in ICU after STA-MCA bypass |
| Date of disclosure of the study information | 2022/09/13 |
| Last modified on | 2022/09/12 23:41:10 |
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Basic information
Public title
Analysis of causes of prolonged ventilatory management after STA-MCA bypass
Acronym
Analysis of causes of prolonged ventilatory management after STA-MCA bypass
Scientific Title
Analysis of causes of prolonged ventilatory management in ICU after STA-MCA bypass
Scientific Title:Acronym
Analysis of causes of prolonged ventilatory management in ICU after STA-MCA bypass
Region
| Japan |
Condition
Condition
superficial artery-middle cerebral artery bypass surgery
Classification by specialty
| Neurosurgery | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the cause of prolonged ventilation after superficial temporal artery-middle cerebral artery bypass surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory complications up to 30 days after STA-MCA bypass
Key secondary outcomes
1.All complications up to 30 days postoperatively
2.hospital days after surgery
3.hospital mortality rate
4.re-intubation rate
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
Adult patients aged 18 years and older admitted to the ICU with tracheal intubation after superficial temporal artery-middle cerebral artery bypass surgery
Key exclusion criteria
1.Patients with underlying factors that may prolong the duration of ventilation.
dysphagia, respiratory failure, cardiac failure, and impaired consciousness.
2. Patients after emergency surgery
3. Pregnant patients
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
junya264@sc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Jun-ya |
| Middle name | |
| Last name | Ishikawa |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
ishikawa.junya@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Women's Medical University Institutional Review Board
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-8111
rinri.bm@twmu.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 | 09 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ZeCT is taken after STA-MCA bypass surgery to check for hyperperfusion. If hyperperfusion is detected, tracheal intubation and mechanical ventilation are continued with deep sedation and blood pressure control until the ZeCT shows that hyperperfusion has improved. Special attention will be paid to the impact of this ventilation and deep sedation on the development of respiratory complications.
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
