UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042610 |
|---|---|
| Receipt number | R000048631 |
| Scientific Title | Accuracy of non-invasive cardiac output in children: prospective observational study |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2025/01/02 09:43:57 |
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Basic information
Public title
Accuracy of non-invasive cardiac output in children
Acronym
Accuracy of non-invasive cardiac output in children
Scientific Title
Accuracy of non-invasive cardiac output in children: prospective observational study
Scientific Title:Acronym
Accuracy of non-invasive cardiac output in children: prospective observational study
Region
| Japan |
Condition
Condition
Pediatric patients
Classification by specialty
| Surgery in general | Pediatrics | Anesthesiology |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of non-invasive cardiac output measurement (esCCO) in pediatric patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of cardiac output and stroke vlome: non-invasive measurement (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
Pediatric patients (under 20 years old)
Scheduled surgery under general anesthesia
Obtain informed consent from parents
Key exclusion criteria
Emergency Surgery
Target sample size
80
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, Nagoya
TEL
+81527442340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Fujiii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Nagoya
TEL
+81527442340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Ethics Committee of Nagoya University Hospital
Address
65 Tsurumai-cho, Nagoya
Tel
+81527442479
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
| 2021 | Year | 04 | 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
60
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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 04 | 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
| 2020 | Year | 12 | Month | 01 | 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=R000048631
