UMIN-CTR Clinical Trial

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
Email	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
Email	moritoc0114@gmail.com

Sponsor
Institute	Hokkaido University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027803