UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050350 |
|---|---|
| Receipt number | R000057041 |
| Scientific Title | Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery. |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2023/09/27 13:41:42 |
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Basic information
Public title
Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.
Acronym
Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.
Scientific Title
Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.
Scientific Title:Acronym
Investigation of the correlation between blood pressure/pulse rate measured at anesthesiologists' interview/self-reported and blood pressure/pulse rate measured during anesthesia/surgery.
Region
| Japan |
Condition
Condition
Patients scheduled for elective surgery with general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, patients scheduled for elective surgery with general anesthesia are the subjects. We investigate the correlation between blood pressure/pulse rate measured prior to, during and after anesthesiologists' interview, self-reported daily blood pressure/pulse rate, and blood pressure/pulse rate during anesthesia induction and surgery procedure.
Basic objectives2
Others
Basic objectives -Others
Secondarily, we also investigate the correlation between blood pressure/pulse rate variability at anesthesiologists' interview, and blood pressure/pulse rate variability during anesthesia induction/surgery procedure.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In patients scheduled for elective surgery with general anesthesia, we investigate the correlation between blood pressure/pulse rate measured prior to, during and after anesthesiologists' interview, self-reported daily blood pressure/pulse rate, and blood pressure/pulse rate during anesthesia induction and surgery procedure. After collecting blood pressure and pulse rate data for all patients, we check the normality of the data by Shapiro-Wilk test, and multiple comparisons are performed for each item using one-way ANOVA and Bonferroni correction.
Key secondary outcomes
We investigate the correlation between the maximum variation in systolic blood pressure, diastolic blood pressure, and pulse rate measured by scheduled surgical patients before/ during/ after their anesthesiology interview before surgery and the maximum variation in systolic blood pressure, diastolic blood pressure, and pulse rate during anesthesia induction/ during surgery. After collecting data for all patients, we check the normality of the data by Shapiro-Wilk test, and multiple comparisons are performed for each item using one-way ANOVA and Bonferroni correction.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)During the period from March 1, 2021 to April 30, 2022
2)Patients who received a preoperative interview by an anesthesiologist at Gunma University Hospital
3)Patients who received general anesthesia
Key exclusion criteria
1) Patients who have difficulty deciding of their own free will to participate in the research (severe dementia, mental retardation, etc.)
2) Patients under 20 years of age
3) Patients who are physically unable to have their blood pressure measured at the upper arm or wrist due to their physique or paralysis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ikuya, Shigeru |
| Middle name | |
| Last name | Koibuchi, Saito |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology and Intensive Care
Zip code
371-8511
Address
Gunma Prefecture, Maebashi-shi, Showa-machi, 3-39-22
TEL
027-220-8454
ikoibuchi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikuya |
| Middle name | |
| Last name | Koibuchi |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology and Intensive Care
Zip code
371-8511
Address
Gunma Prefecture, Maebashi-shi, Showa-machi, 3-39-22
TEL
027-220-8454
Homepage URL
ikoibuchi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Ikuya Koibuchi
Funding Source
Organization
Gunma University 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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
Gunma Prefecture, Maebashi-shi, Showa-machi, 3-39-15
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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
群馬大学医学部附属病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 15 | 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
185
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Whilst the anesthesiologist's interview at Department of Anesthesiology and Intensive Care Medicine at Gunma University Hospital,as part of routine medical care, blood pressure is measured three times; before, during, and after the interview. It is used as blood pressure reference before actual general anesthesia. First, in the outpatient clinic, we gather information of "self-reported blood pressure", a daily systolic and diastolic blood pressures measured at home or during physical examinations at work reported by the patient, and record in the patient's medical record. At the same time, the presence or absence of a blood pressure diary that records the subject's usual blood pressure is also checked. Next, during preoperative interviews and information gathering (height, weight, underlying diseases, medical history, and preoperative examination results), we measure blood pressure three times; before, during, and after the interview, and record in the patient's medical record. In this study, we will analyze the recorded blood pressure during anesthesia and surgery, focusing on the lowest blood pressure immediately before and after induction of anesthesia, the lowest blood pressure during surgery, and the highest blood pressure during surgery/anesthesia induction, and create scatter plots and perform correlation analysis. In order to compare with previous studies, we will also examine the factors that are likely to cause blood pressure fluctuations and perform multiple regression analysis.
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057041
