None listed
Conditions
Interventions
Medical Device : This study is designed as a prospective, single-center, randomized, controlled, open-label, parallel-group clinical trial. All patients will provide written informed consent after rec
Sponsors
The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be eligible for inclusion if all of the following criteria are met: 1. Adults aged 19 years or older. 2. Patients undergoing major abdominal surgery under general anesthesia. For the purposes of this study, major abdominal surgery is defined as a procedure meeting one of the following criteria: Upper gastrointestinal surgery: total gastrectomy, distal gastrectomy, proximal gastrectomy, or surgery involving the esophagogastric junction. Lower gastrointestinal surgery: right or left hemicolectomy, low anterior resection, anterior resection, total colectomy, abdominoperineal resection, or segmental small bowel resection with anastomosis. Hepatobiliary and pancreatic surgery: hepatic resection (=1 segment), right or left hepatectomy, central hepatectomy, distal pancreatectomy, pancreaticoduodenectomy (Whipple procedure), or bile duct resection with reconstruction. Other moderate-to-high complexity intra-abdominal procedures involving major organ resection and/or reconstruction: such as complex cholecystectomy requiring extensive adhesiolysis, intra-abdominal tumor resection, or other procedures judged by the principal investigator to constitute major abdominal surgery. 3. Actual anesthetic duration of =3 hours at the time of completion of surgery. 4. Patients who are eligible for immediate extubation at the end of surgery and can be transferred to the post-anesthesia care unit (PACU) or intensive care unit (ICU) while breathing spontaneously. 5. Patients who have provided written informed consent before surgery. However, final enrollment will be confirmed only if the actual anesthetic duration and the procedure performed after surgery meet the inclusion criteria.
Exclusion criteria
Exclusion criteria: Participants will be excluded if any of the following criteria are met: 1. Requirement for invasive mechanical ventilation after completion of surgery. 2. Failure of immediate extubation after surgery. 3. Inability to undergo routine postoperative recovery because of severe intraoperative hemodynamic instability, massive bleeding, cardiopulmonary resuscitation, or other major intraoperative events. 4. Requirement for continuous oxygen therapy, non-invasive ventilation (NIV), or invasive mechanical ventilation (IMV) before surgery. 5. History of thoracic surgery within the preceding 4 weeks that may confound postoperative respiratory assessment. 6. Inability to apply high-flow nasal cannula (HFNC) because of upper airway anatomical abnormalities or other technical limitations. 7. Planned reoperation already determined at the time of completion of surgery. 8. Inability to provide valid participation or complete follow-up because of impaired decision-making capacity or anticipated impracticality of follow-up. 9. Any condition that, in the judgment of the investigator, makes participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically significant postoperative pulmonary complications (PPCs) within 7 postoperative days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of pneumonia within 7 postoperative days;Incidence of respiratory failure within 7 postoperative days;Incidence of clinically significant atelectasis within 7 postoperative days;Incidence of clinically significant pleural effusion within 7 postoperative days;Requirement for escalation of respiratory support (non-invasive ventilation or invasive mechanical ventilation) within 7 postoperative days;Length of ICU stay;Length of hospital stay;All-cause mortality within 30 days after surgery | — |
Countries
Korea, Republic of
Contacts
Public ContactJinbeom Cho
The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
Outcome results
None listed