臨床研究等提出・公開システム

Date of registration	May. 15, 2026
Last modified on	May. 15, 2026
Trial ID	jRCT1020260007

Scientific Title	Association between postoperative cognitive dysfunction and persistent dysphagia after general anesthesia for cardiac and thoracic vascular surgery: a retrospective cohort study
Public Title	A study examining the relationship between delirium and the status of eating and drinking by mouth after cardiac and thoracic vascular surgery

Contact for Scientific Queries	Name	Tamura Ippei
	Affiliation	Hirosaki University Graduate School of Medicine
	Address	53 Hon-cho, Hirosaki, Aomori
	Telephone	+81-172-39-5318
	E-mail	h24gm208@hirosaki-u.ac.jp
Contact for Public Queries	Name	Tamura Ippei
	Affiliation	Hirosaki University Graduate School of Medicine
	Address	53 Hon-cho, Hirosaki, Aomori
	Telephone	+81-172-39-5318
	E-mail	h24gm208@hirosaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 15, 2026
Target sample size		700
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	screening
Key inclusion & exclusion criteria	Inclusion Criteria	1) Adult patients who underwent open cardiac or thoracic aortic surgery under general anesthesia at Hirosaki University Hospital between September 1, 2021 and August 31, 2025, and who were admitted to the ICU postoperatively. 2) Patients who can be identified from our institutional data registered in the Japanese Intensive care PAtient Database (JIPAD) as having undergone coronary artery bypass grafting, coronary artery bypass grafting plus valve surgery, valve surgery, surgery for acute aortic dissection, surgery for ruptured aortic aneurysm, or elective surgery for aortic aneurysm.
	Exclusion Criteria	1) Patients younger than 18 years of age. 2) Patients who underwent surgery without thoracotomy. 3) Patients with preoperative dysphagia. 4) Patients with a history of intracerebral hemorrhage, cerebral infarction, dementia, or intellectual disability. 5) Patients with a history of progressive neuromuscular disease. 6) Patients who required reintubation or surgical re-exploration for postoperative bleeding or pericardial tamponade. 7) Patients whose primary outcome could not be evaluated. 8) Patients who died during hospitalization.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ischemic, valvular, and aortic diseases, and other heart diseases
Health Condition(s) Keyword		Myocardial Ischemia, Acute Coronary Syndrome, Myocardial Infarction, Angina Pectoris, Heart Valve Diseases, Aortic Dissection, Aortic Aneurysm, Cardiomyopathies, Endocarditis, Heart Diseases
Health Condition(s) Code		D017202, D054058, D009203, D000787, D006349, D000784, D001014, D009202, D004696, D006331
Primary Outcome(s)		Functional Oral Intake Scale (FOIS) level at day 14 after ICU admission
Secondary Outcome(s)		1) Highest Intensive Care Delirium Screening Checklist (ICDSC) score recorded within 7 days after ICU admission 2) Presence of an ICDSC score of 3 or higher within 7 days after ICU admission 3) Patient characteristics, including age, sex, and body mass index (BMI) 4) Acute Physiology and Chronic Health Evaluation II (APACHE II) score 5) Surgical category 6) Presence of chronic comorbidities 7) Use of intra-aortic balloon pumping and extracorporeal membrane oxygenation during the ICU stay 8) Tracheostomy during the ICU stay 9) ICU length of stay and hospital length of stay 10) Total intubation duration

Primary Sponsor	N/A

Name of Certified Review Board	Ethics Committee of Hirosaki University Graduate School of Medicine
Address	5 Zaifu-cho, Hirosaki, Aomori, Aomori
Telephone	+81-172-33-5111
E-Mail	med-pr@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	April. 09, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none