臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 06, 2024
Last modified on	Dec. 06, 2024
Trial ID	jRCT1020240042

Scientific Title	Observational study of risk factors for death during surgery under general anesthesia using artificial intelligence
Public Title	Observational study on risk factors for death during surgery under general anesthesia

Contact for Scientific Queries	Name	Hoshijima Hiroshi
	Affiliation	Tohoku University Graduate School of Dentistry
	Address	Seiryomachi 4-1, Aoba, Sendai, Miyagi, 980-8575, Japan
	Telephone	+81-22-717-8420
	E-mail	hhoshi6@gmail.com
Contact for Public Queries	Name	Hoshijima Hiroshi
	Affiliation	Tohoku University Graduate School of Dentistry
	Address	Seiryomachi 4-1, Aoba, Sendai, Miyagi, 980-8575, Japan
	Telephone	+81-22-717-8420
	E-mail	hhoshi6@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		Dec. 06, 2024
Actual date of first enrollment		Oct. 01, 2024
Target sample size		65000
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who underwent non-cardiac surgery under general anesthesia at Tohoku University Hospital Men and women aged 18 or older
	Exclusion Criteria	Patients under 18 years of age and those undergoing cardiac and open chest surgery
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Adults Patients undergoing non-cardiac surgery under general anesthesia
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword		Artificial intelligence, mortality, risk factor
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Patient mortality within 30 days after surgery
Secondary Outcome(s)		Cause of death, Days from surgery to discharge (discharge), Over 18 years old, Age, height, weight, BMI, Surgery time, anesthesia time, amount of infusion, amount of blood loss, amount of blood transfusion, amount of urine, Surgery department (orthopedics, etc.), type of surgery (cholecystectomy), Open surgery, laparoscopic surgery, Combined with epidural anesthesia, Sevoflurane, desflurane, suprene, propofol, diprivan, remifentanil, altiba, fentanyl, Amount of rocuronium and sugammadex used (whether or not used), Amount of ephedrine, atropine sulfate, neosynedine, perdipine, alprostadil alfadex, herbesser, adrenaline, inovan, noradrenaline, meylon, linden, lasix, furosemide, calcicol, onoact, landiolol, sigmart, nicorandil, solumedrol used (whether or not used), Whether or not extubation was performed, number of days until extubation for intubated patients admitted to the ICU, ASA classification, time of admission to the operating room, vital signs at admission to the operating room (blood pressure, pulse, saturation)

Primary Sponsor	None

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tohoku University, Tohoku Clinical Research Review Committee
Address	2-1-1 Katahira, Aoba-ku, Sendai City, Miyagi
Telephone	+81-22-718-0461
E-Mail	office@nrs.hosp.tohoku.ac.jp
Approval Status	Approval
Date of approval	Nov. 14, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	None