UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023313 |
|---|---|
| Receipt number | R000026484 |
| Scientific Title | Investigation of the accuracy of the cardiac output measurement using two different minimally invasive cardiac output monitoring system |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2024/01/29 09:50:45 |
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Basic information
Public title
Investigation of the accuracy of the cardiac output measurement using two different minimally invasive cardiac output monitoring system
Acronym
Investigation of the accuracy of the cardiac output measurement using two different minimally invasive cardiac output monitoring system
Scientific Title
Investigation of the accuracy of the cardiac output measurement using two different minimally invasive cardiac output monitoring system
Scientific Title:Acronym
Investigation of the accuracy of the cardiac output measurement using two different minimally invasive cardiac output monitoring system
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of accuracy and trend of the accuracy of Flo Trac and LiDCO rapid
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of accuracy and trend of the accuracy of Flo Trac and LiDCO rapid compared with intermittent thermodilution using pulmonary artery catheter during cardiovascular surgery.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients older than 20 years undergoing cardiac surgery with cardiopulmonary bypass in Tohoku University Hospital
Key exclusion criteria
withdrawal of consent
moderate or more aortic valve stenosis or regurgitation
intra aortic balloon pumping
extracorporeal membrane system
left ventricular assist device
thoracic aorta placement
moderate or more tricuspid regurgitation
low cardiac output
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Toyama |
Organization
Tohoku University Hospital
Division name
department of anesthesiology
Zip code
980-8574
Address
1-1 seiryoumachi, Aobaku, Sendaishi, Miyagi
TEL
022-717-7406
h-toyama@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takei |
| Middle name | |
| Last name | Yusuke |
Organization
Tohoku University Hospital
Division name
department of anesthesiology
Zip code
9809574
Address
1-1 seiryoumachi, Aobaku, Sendaishi, Miyagi
TEL
022-717-7321
Homepage URL
y-takei@xf7.so-net.ne.jp
Sponsor or person
Institute
Tohoku University Hospital
department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Tohoku University Hospital
Address
1-1 seiryoumachi, Aobaku, Sendaishi, Miyagi
Tel
022-717-7321
ytakei@med.tohoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
Tohoku University Graduate School of Medicine Ethi
Org. issuing International ID_1
2015-1-845
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026484
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
29
Results
Twenty-nine patients were enrolled. Compared with CITD, CIFT and CILR had a percentage error (PE) of 39.9% and 51.2%, respectively. The accuracy of CIFT or CILR is not clinically acceptable. Fourth-generation Flotrac was unreliable in high-SVRI. LiDCOrapid was inaccurate across a broad range of SVRI and minimally affected by SVRI.
Results date posted
| 2024 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult patients undergoing cardiovascular surgery with a cardio-pulmonary bypass e monitoring with pulmonary artery catheter at Tohoku University Hospital
Participant flow
Written informed consent was obtained from all participants who were considered eligible for this clinical trial.
Adverse events
None.
Outcome measures
The reliablity (FloTrac and LiDCOrapid) of two APCO devices were investigated compared with thermodilution technique using pulmonary artery catheter. The correlation between CIFT or CILR and CITD was examined using Pearson's rank correlation coefficient; p values < 0.05 were considered statistically significant. Bland-Altman analysis was performed to evaluate the agreement of each APCO device (CIFT or CILR) with the reference method (CITD). The bias, the limit of agreement and percentage error were calculated for all sets of CIs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This trial ended in May 2018.
Management information
Registered date
| 2016 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026484
