UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024824
Receipt No. 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 (Ver. 10)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Email 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
Email yokose_p12@yahoo.co.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026530