NIPH Clinical Trials Search

A study examining the relationship between delirium and the status of eating and drinking by mouth after cardiac and thoracic vascular surgery

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ischemic, valvular, and aortic diseases, and other heart diseases
Date of first enrollment	15/05/2026
Target sample size	700
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

Functional Oral Intake Scale (FOIS) level at day 14 after ICU admission

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.