UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024824 |
|---|---|
| Receipt number | R000026530 |
| Scientific Title | The accuracy of the non-invasive continuous arterial pressure monitoring that is adjusted with perfusion index: A method comparison study. |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2019/10/30 23:51:43 |
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Basic information
Public title
The accuracy of the non-invasive continuous arterial pressure monitoring that is adjusted with perfusion index: A method comparison study.
Acronym
Non-invasive continuous arterial pressure monitoring and perfusion index
Scientific Title
The accuracy of the non-invasive continuous arterial pressure monitoring that is adjusted with perfusion index: A method comparison study.
Scientific Title:Acronym
Non-invasive continuous arterial pressure monitoring and perfusion index
Region
| Japan |
Condition
Condition
Patients who are undergoing to the planed hepatectomy or pancreaticoduodenectomy with general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to evaluate whether perfusion index can indicate the low accuracy range of the non-invasive continuous blood pressure monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The standard deviation of the bias between arterial pressures obtained by ClearSight versus by an arterial catheter.
The bias and 95% limits of agreement of arterial blood pressure between two devices (Bland-Altman method for repeated measurements)
Key secondary outcomes
(1) The beta coefficient of the bias using the linear mixed-effects model between arterial pressures obtained with ClearSight versus with an arterial catheter
(2) The percentage error of the arterial pressure
(3) Interclass correlation coefficients of the arterial pressure
(4) The beta coefficient of the CO, SV, SVV calculated by the mixed linier regression model.
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
Patients who are undergoing to elective hepatectomy or pancreaticoduodenectomy by general anesthesia.
Key exclusion criteria
(1)body weight < 40 or >180 kg, BMI > 35kg/m2
(2)History of Raynaud syndrome and related diseases
(3)Hystory of atrial fibrillation
(4)History of the brachial vascular surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
+81457872800
yokose_p12@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
+81457872800
Homepage URL
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
Institutional ethics committee of the Yokohama City University Hospital
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
+81453707627
rinri@yokohama-cu.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
| 2017 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0219511
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0219511
Number of participants that the trial has enrolled
30
Results
Compared with the case of PI>1, the adjusted SD of bias in the case of PI<=1 was 1.4 times (95% confidence interval; 1.3 to 1.4) in systolic arterial pressure, 1.5 times (95% confidence interval 1.3 to 1.6) in diastolic arterial pressure, and 1.3 times (95% confidence interval 1.2-1.5) in mean arterial pressure.
Results date posted
| 2019 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 07 | Month | 10 | Day |
Baseline Characteristics
6448 data points were obtained from 30 parturients.
Participant flow
The number of the excluded individual was 0.
136 data points were excluded because of the artefact and missing data.
Adverse events
None
Outcome measures
The ratio of the adjusted SD of bias between PI<=1 and PI>1.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An invasive arterial catheter (FloTrac sensor)is inserted to the left radial artery after induction of the gengeral anesthesia. ClearSight finger cuff and probe of the pulse oximeter are also attached to the left hand finger.
Data collection: arterial blood pressure, cardiac output, stroke volume, stroke volume variation, perfusion index, and body temperature.
Data collection period:
One measurement period: 15 minutes
one data point: averages of 1 minute blood pressure data
-Operating room
The measuring period will be set at least 8 times during operation.
We plan to collect more than 120 points (i.e. 8*15=120 points) per one patient.
-Intensive care unit
Performing at least 2 data collection periods from 1 hour to 4 hours after entering the intensive care unit.(i.e. 2*15=30 points per one patient)
Anesthetic or post operative management were at the discretion of the attending anesthesiologist.
Data collection period: 24 hours later from data collection start at the operative room or 4 hours later from admission on ICU
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026530
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