UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055781 |
|---|---|
| Receipt number | R000062432 |
| Scientific Title | A retrospective study of perioperative airway management in patients undergoing cardiac surgery for trisomy 18 |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2024/10/08 10:59:14 |
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Basic information
Public title
A retrospective study of perioperative airway management in patients undergoing cardiac surgery for trisomy 18
Acronym
A retrospective study of perioperative airway management in patients undergoing cardiac surgery for trisomy 18
Scientific Title
A retrospective study of perioperative airway management in patients undergoing cardiac surgery for trisomy 18
Scientific Title:Acronym
A retrospective study of perioperative airway management in patients undergoing cardiac surgery for trisomy 18
Region
| Japan |
Condition
Condition
torisomy 18
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consideration of airway complications
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
airway complications
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are patients with trisomy 18 syndrome who are being treated at our hospital and who have undergone cardiac surgery. Cardiac surgery includes palliative surgery such as pulmonary artery banding and radical surgery such as ventricular septal patch closure.
Key exclusion criteria
Research subjects judged by the research director or attending physician to be unsuitable for safely conducting this research
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Fujisawa |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Anesthesiology
Zip code
5698686
Address
2-7 Daigakucho, Takatsuki City, Osaka Prefecture
TEL
09051503883
takanobu.fujisawa@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Fujisawa |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Anesthesiology
Zip code
5698686
Address
2-7 Daigakucho, Takatsuki City, Osaka Prefecture
TEL
09051503883
Homepage URL
takanobu.fujisawa@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Takanobu Fujisawa
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University
Address
2-7 Daigakucho, Takatsuki City, Osaka Prefecture
Tel
09051503883
takanobu.fujisawa@ompu.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
大阪府
Institutions
Institutions
大阪医科薬科大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 08 | 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
32
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
| 2024 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062432
