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Starting soon Not applicable

High-Flow Nasal Cannula After Major Abdominal Surgery to Prevent Postoperative Pulmonary Complications

NCT07528404 · tracked via the Priya Life Science South Korea tracker
Sponsor
Uijeongbu St. Mary Hospital
Phase
Not applicable
Started
2026-07-01
Last updated
2026-04-14

Condition(s) studied

Postoperative ComplicationsAtelectasisPneumoniaRespiratory Insufficiency

Investigational drug(s) / intervention(s)

High flow nasal cannula (HFNC)Standard oxygen therapy

High flow nasal cannula (HFNC): High-flow nasal cannula (HFNC) will be applied prophylactically immediately after extubation following major abdominal surgery. Heated and humidified oxygen will be delivered through a high-flow nasal cannula system and maintained for 24 hours postoperatively according to the study protocol.

Standard oxygen therapy: Standard postoperative oxygen therapy will be administered immediately after extubation following major abdominal surgery according to usual institutional practice and the study protocol, without prophylactic high-flow nasal cannula.

Study summary

Major abdominal surgery is associated with a substantial risk of early postoperative pulmonary complications, including atelectasis, hypoxemia, pneumonia, and increased need for respiratory support. High-flow nasal cannula (HFNC) provides warmed and humidified oxygen at high flow rates and may improve oxygenation, reduce respiratory workload, and support lung volume during the immediate postoperative period. However, whether routine prophylactic HFNC after major abdominal surgery reduces clinically significant postoperative pulmonary complications remains uncertain.

This prospective, single-center, randomized controlled trial will evaluate whether prophylactic HFNC applied for 24 hours immediately after extubation reduces postoperative pulmonary complications compared with standard postoperative respiratory care in adult patients undergoing major abdominal surgery under general anesthesia with an actual anesthetic duration of 3 hours or longer.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged 19 years or older. * Undergoing major abdominal surgery under general anesthesia. * Major abdominal surgery is defined as one of the following: 1. Upper gastrointestinal surgery: total gastrectomy, distal gastrectomy, proximal gastrectomy, or esophagogastric junction surgery. 2. Lower gastrointestinal surgery: right or left hemicolectomy, low anterior resection, anterior resection, total colectomy, abdominoperineal resection, or segmental small bowel resection with anastomosis. 3. 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. 4. Other moderate-to-major intra-abdominal procedures involving major organ resection or reconstruction, as determined by the investigator (e.g., complex cholecystectomy with extensive adhesiolysis, intra-abdominal tumor resection). * Actual anesthetic duration ≥ 3 hours, confirmed at the end of surgery. * Able to undergo immediate extubation at the end of surgery and be transferred to the post-anesthesia care unit or intensive care unit with spontaneous breathing. * Provided written informed consent before surgery. Final enrollment will occur only if the actual surgical procedure and anesthetic duration meet all eligibility criteria after surgery. Exclusion Criteria: * Requirement for postoperative invasive mechanical ventilation. Failed extubation immediately after surgery. * Severe intraoperative instability preventing routine postoperative recovery (e.g., major hemodynamic instability, massive bleeding, or cardiopulmonary resuscitation). * Requirement for continuous oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation before surgery. * Thoracic surgery within 4 weeks before the index surgery. Inability to receive HFNC because of upper airway or nasal anatomical limitations. * Planned reoperation at the completion of the index surgery. * Inability to complete study participation or follow-up because of impaired decision-making capacity or practical inability to complete follow-up. * Any condition that, in the investigator's judgment, makes study participation inappropriate.

Primary outcome measure(s)

  • Postoperative pulmonary complications (PPCs) — Within 7 days after surgery
    The primary outcome is the incidence of clinically significant postoperative pulmonary complications (PPCs) within 7 days after surgery. PPCs will be evaluated as a composite endpoint according to predefined criteria in the study protocol.

Trial sites (1)

FacilityCityRegionStatus
Jinbeom cho Uijeongbu-si South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07528404 on ClinicalTrials.gov ↗ ← All trials in South Korea