UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028257 |
|---|---|
| Receipt number | R000027803 |
| Scientific Title | A study of the clinical utility of cerebral and somatic mixed blood oxygen saturation measurement using a noninvasive monitor of mixed blood oxygen saturation (INVOS) during pediatric congenital heart surgery. |
| Date of disclosure of the study information | 2017/07/18 |
| Last modified on | 2022/03/13 23:11:19 |
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Basic information
Public title
A study of the clinical utility of cerebral and somatic mixed blood oxygen saturation measurement using a noninvasive monitor of mixed blood oxygen saturation (INVOS) during pediatric congenital heart surgery.
Acronym
A study of the clinical utility of cerebral and somatic INVOS during pediatric congenital heart surgery.
Scientific Title
A study of the clinical utility of cerebral and somatic mixed blood oxygen saturation measurement using a noninvasive monitor of mixed blood oxygen saturation (INVOS) during pediatric congenital heart surgery.
Scientific Title:Acronym
A study of the clinical utility of cerebral and somatic INVOS during pediatric congenital heart surgery.
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Pediatrics | Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate perioperative changes on c-rSO2 and s-rSO2 during pediatric congenital heart surgery, and examine 1) how they relate to circulatory / respiratory dynamics changes at the perioperative period, and 2) how they relate to postoperative prognosis including complications.
Basic objectives2
Others
Basic objectives -Others
Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between c-rSO2 and s-rSO2 over time and perioperative circulation / respiratory dynamics
Observational items:Blood pressure, central venous pressure, central venous oxygen saturation, oxygen partial pressure, partial pressure of carbon dioxide, and pH, etc.
Key secondary outcomes
Relationship between c-rSO2 and s-rSO2 over time and postoperative prognosis
Observational items:postoperative low output state(LOS), acute kidney injury(AKI), postoperative intubation time, ICU stay duration, complications within one month after operation, and life prognosis
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
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
body weight less than 10 kg
Key exclusion criteria
1. Patients who have other organ complications
2. Patients who have been judged inappropriate by principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morimoto |
Organization
Hokkaido University Hospital
Division name
Department of Anesthesiology
Zip code
060-8648
Address
Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
TEL
+81-11-706-5732
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Mori |
Organization
Hokkaido University Hospital
Division name
Department of Anesthesiology
Zip code
060-8648
Address
Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
TEL
+81-11-706-5732
Homepage URL
moritoc0114@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
none
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
Hokkaido University Hospital Clinical research and Medical Innovation Center
Address
Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
Tel
+81-11-706-5732
crjimu@huhp.hokudai.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 | 07 | Month | 18 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00246-020-02492-y
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00246-020-02492-y
Number of participants that the trial has enrolled
41
Results
Through the whole surgical period, ScO2 correlated strongly with mean blood pressure regardless of the physiological type. On the other hand, the contribution of mean blood pressure to SrO2 was weak and various other parameters were related to SrO2 changes. Thus, the physiological parameters affecting ScO2 and SrO2 were rather different.
Results date posted
| 2022 | Year | 03 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Children whose body weight was less than 10 kg and who were scheduled for cardiac surgery with CPB were examined. Children with complications of other organs were excluded.
Participant flow
This prospective observational study was approved by Institutional Review Board of the Hokkaido University Hospital, and the written informed consent was obtained from the parents of all subjects participating in the trial.
Adverse events
none
Outcome measures
ScO2 and SrO2 were measured with an INVOS 5100C. Mean arterial pressure(MAP), central venous pressure(CVP), and rectal temperature were also obtained every one minute. Arterial blood gases were analyzed at 37 Celsius intermittently, and the arterial oxygen saturation(SaO2), PaCO2, pH and hematocrit were obtained.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 01 | Day |
Other
Other related information
prospective observational study
Management information
Registered date
| 2017 | Year | 07 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027803
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