UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048251 |
|---|---|
| Receipt number | R000054994 |
| Scientific Title | Verification study for accuracy of non-invasive cardiac output measurement in children |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2025/01/02 09:46:07 |
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Basic information
Public title
Verification study for accuracy of non-invasive cardiac output measurement in children
Acronym
Verification study for accuracy of esCCO in children
Scientific Title
Verification study for accuracy of non-invasive cardiac output measurement in children
Scientific Title:Acronym
Verification study for accuracy of esCCO in children
Region
| Japan |
Condition
Condition
Pediatric patients under general anesthesia
Classification by specialty
| Pediatrics | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the accuracy of non-invasive continuous estimated cardiac output measurements (esCCO) with software updates in pediatric patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the accuracy of cardiac output measurements between updated esCCO and transthoracic echocardiography
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
| Not applicable |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Scheduled surgery
Obtained informed consent
Key exclusion criteria
Congenital heart disease
Not obtained informed consent
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kimitoshi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81527442340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Fujii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527442340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Nagoya University Hospital Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
0527442479
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1213/ane.0000000000007144
Number of participants that the trial has enrolled
80
Results
Cardiac output measurement by esCCO with modified coefficients for pediatric patients showed high accuracy and tracking ability compared with cardiac output measurement by transthoracic echocardiography. In Bland-Altman analysis, the bias (standard deviation), 95% limits of agreement, and percentage error were 0.03(0.28), -0.53 to 0.60, and 18% in the preoperative measurement, and -0.04(0.19), -0.42 to 0.35, and 15% in the postoperative measurement, respectively.
Results date posted
| 2025 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054994
