UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009798 |
|---|---|
| Receipt number | R000011473 |
| Scientific Title | Preoperative Pulse Wave Velocity and Augmentation index can predict hemodynamic changes during general anesthesia |
| Date of disclosure of the study information | 2013/01/17 |
| Last modified on | 2013/01/17 19:30:55 |
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Basic information
Public title
Preoperative Pulse Wave Velocity and Augmentation index can predict hemodynamic changes during general anesthesia
Acronym
Arteriosclerosis and hemodynamic changes during anesthesia
Scientific Title
Preoperative Pulse Wave Velocity and Augmentation index can predict hemodynamic changes during general anesthesia
Scientific Title:Acronym
Arteriosclerosis and hemodynamic changes during anesthesia
Region
| Japan |
Condition
Condition
Circulation disease
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The patients aged 40 years old or more(ASA PS 1 or 2) are enrolled. We measure the Pulse wave velocity (PWV), Augmentation index (AI) and central blood pressure which reflects the level of arterial occlusion and sclerosis, and evaluate whether it is possible to predict the excessive hemodynamic changes during anesthesia induction and tracheal intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relation between the values of PWV, AI and central blood pressure, and the changes of blood pressure during anesthesia induction and tracheal intubation
Key secondary outcomes
Effects of age, preoperative blood pressure and antihypertensive drugs etc. to above primary 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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients aged 40 years old or more, who underwent anesthesia induction and tracheal (ASA PS 1 or 2)
Key exclusion criteria
The patients who have ASA PS 3 or more
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinari MORIMOTO |
Organization
Graduate School of Dentistry, Osaka University
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamada-oka, Suita, 565-0871, Japan
TEL
06-6879-2972
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinari MORIMOTO |
Organization
Graduate School of Dentistry, Osaka University
Division name
Department of Dental Anesthesiology
Zip code
Address
1-8, Yamada-oka, Suita, 565-0871, Japan
TEL
06-6879-2972
Homepage URL
ysn-mori@dent.osaka-u.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology, Graduate School of Dentistry, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Sciences Research Grant
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
大阪大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 17 | 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
Completed
Date of protocol fixation
| 2006 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 17 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 31 | Day |
Other
Other related information
The patients aged 40 years old or more, who underwent oral and maxillofacial surgery (ASA PS 1 or 2), were enrolled. The preoperative systolic blood pressure (SBP), dyastolic blood pressure (DBP), heart rate (HR), brachial-ankle PWV (baPWV), Augmentation index and central blood pressure were measured on the day before operation.
The fluctuation in SBP and DBP were measured during anesthesia induction and tracheal intubation. The difference between the highest or lowest value of SBP during anesthesia and each preoperative value were compared. The difference of DBP was compared in the same way. Then the predictive fectors for hemodynamic changes were determined.
Management information
Registered date
| 2013 | Year | 01 | Month | 17 | Day |
Last modified on
| 2013 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011473
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
