臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 30, 2025
Last modified on	Jan. 30, 2025
Trial ID	jRCT1042240179

Scientific Title	A comparative study of noninvasive cardiac output measurement methods in pediatric patients
Public Title	A comparative study of noninvasive cardiac output measurement methods in pediatric patients

Contact for Scientific Queries	Name	Tasuku Fujii
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
	Telephone	+81-527442340
	E-mail	plus9@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Tasuku Fujii
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
	Telephone	+81-52-744-2340
	E-mail	plus9@med.nagoya-u.ac.jp

Recruitment status	Pending


Anticipated date of first enrollment		Jan. 30, 2025
Target sample size		30
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing surgery under general anesthesia Patients entering the intensive care unit Patients under 15 years old
	Exclusion Criteria	Emergency surgery Parental consent not obtained
	Age Minimum	No limit
	Age Maximum	15age old not
Health Condition(s) or Problem(s) Studied		Diseases for which surgery is performed under general anesthesia
Health Condition(s) Code		D000768
Primary Outcome(s)		Comparison of accuracy of paired echocardiographic and esCCO cardiac output measurements , Comparison of accuracy of paired echocardiographic and aesculon cardiac output measurements (Bland-Altman analysis)
Secondary Outcome(s)		Comparison of cardiac output change tracking using Polar plot analysis

Primary Sponsor	Nihon Kohden

Source of Monetary Support / Secondary Sponsor	Nihon Kohden
Secondary Sponsor

Name of Certified Review Board	Nagoya University Hospital Ethics Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 14, 2025

Plan to share IPD	Yes
Plan description	The following data will be de-identified and then shared with Nihon Kohden Corporation via a file sharing system. Measurements by transthorathic echocardiography, esCCO, and aesculon: cardiac output, stroke volume, and age, gender, height, weight, medical history (birth and developmental history), surgical procedure, anesthesia method, anesthesia record data (blood pressure, pulse rate, oxygen saturation, body temperature, intubation/extubation time, intraoperative bleeding volume, intraoperative balance, volume of infusion, urine volume, body position)

Plan to share IPD

Yes

Plan description

The following data will be de-identified and then shared with Nihon Kohden Corporation via a file sharing system. Measurements by transthorathic echocardiography, esCCO, and aesculon: cardiac output, stroke volume, and age, gender, height, weight, medical history (birth and developmental history), surgical procedure, anesthesia method, anesthesia record data (blood pressure, pulse rate, oxygen saturation, body temperature, intubation/extubation time, intraoperative bleeding volume, intraoperative balance, volume of infusion, urine volume, body position)

Countries of Recruitment（Except Japan）	none