UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014839 |
|---|---|
| Receipt number | R000017244 |
| Scientific Title | An observation of cardiac function with transesophageal echocardiography during sitting-positioned neurosurgery. |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2017/08/14 20:41:05 |
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Basic information
Public title
An observation of cardiac function with transesophageal echocardiography during sitting-positioned neurosurgery.
Acronym
An observation of cardiac function with transesophageal echocardiography during sitting-positioned neurosurgery.
Scientific Title
An observation of cardiac function with transesophageal echocardiography during sitting-positioned neurosurgery.
Scientific Title:Acronym
An observation of cardiac function with transesophageal echocardiography during sitting-positioned neurosurgery.
Region
| Japan |
Condition
Condition
Patients who recieved neurosurgery in sitting position.
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hemodynamic effect of sitting position during neurosurgery is not well investigated. We investigate the hemodynamics during sitting neurosurgery with transesophageal echocardiography.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac function during sitting neurosurgery.
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent neurosurgery in sitting position.
Key exclusion criteria
Patients for whom transesophageal echocardiography is contraindication.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Iida |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
1-1 Yanagido, Gifu, Gifu 501-1194, Japan
TEL
+81-58-230-6404
iida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimito Minami |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
Address
1-1 Yanagido, Gifu, Gifu, Japan
TEL
+81-58-230-6404
Homepage URL
nann_5115@ybb.ne.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine, Department of Anesthesiology and Pain 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
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
| 2014 | Year | 10 | 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
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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate cardiac function of the patients who underwent neurosurgery in sitting position.
Management information
Registered date
| 2014 | Year | 08 | Month | 12 | Day |
Last modified on
| 2017 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017244
