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

NCT07528404 | Not Yet Recruiting

• 1 other identifier: UC26DISI0004
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complications; Atelectasis; Pneumonia; Respiratory Insufficiency

Keywords

High-flow nasal cannula; HFNC; PPC; Major abdominal surgery; Postoperative respiratory support; Postoperative pulmonary complications; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Postoperative pulmonary complications (PPCs)

  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.

  Within 7 days after surgery

Secondary Outcomes (7)

• Postoperative pneumonia

  Within 7 days after surgery

• Clinically significant postoperative atelectasis

  Within 7 days after surgery

• Postoperative respiratory failure

  Within 7 days after surgery

• Length of postoperative hospital stay

  From surgery to hospital discharge (up to 30 days)

• Length of postoperative intensive care unit stay

  From postoperative ICU admission to ICU discharge (up to 30 days)

Study Arms (2)

HFNC group

EXPERIMENTAL

Participants randomized to this arm will receive prophylactic high-flow nasal cannula (HFNC) immediately after extubation following major abdominal surgery. HFNC will be initiated in the post-anesthesia care unit or intensive care unit and maintained for 24 hours postoperatively according to the study protocol.

Device: High flow nasal cannula (HFNC)

Standard oxygen group

ACTIVE COMPARATOR

Participants randomized to this arm will receive standard postoperative oxygen therapy immediately after extubation following major abdominal surgery. Oxygen will be administered according to usual institutional practice and the study protocol, without prophylactic high-flow nasal cannula.

Other: Standard oxygen therapy

Interventions

High flow nasal cannula (HFNC) DEVICE

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.

HFNC group

Standard oxygen therapy OTHER

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.

Standard oxygen group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older.
• Undergoing major abdominal surgery under general anesthesia.
• Major abdominal surgery is defined as one of the following:
• Upper gastrointestinal surgery: total gastrectomy, distal gastrectomy, proximal gastrectomy, or esophagogastric junction surgery.
• 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-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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uijeongbu St. Mary Hospital: lead

Study Sites (1)

Jinbeom cho

Uijeongbu-si, 11765, South Korea

Location

Related Publications (5)

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 BACKGROUND

• D'Cruz RF, Hart N, Kaltsakas G. High-flow therapy: physiological effects and clinical applications. Breathe (Sheff). 2020 Dec;16(4):200224. doi: 10.1183/20734735.0224-2020.

  PMID: 33664838 BACKGROUND

• Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.

  PMID: 27771739 BACKGROUND

• Okuda M, Tanaka N, Naito K, Kumada T, Fukuda K, Kato Y, Kido Y, Okuda Y, Nohara R. Evaluation by various methods of the physiological mechanism of a high-flow nasal cannula (HFNC) in healthy volunteers. BMJ Open Respir Res. 2017 Jul 20;4(1):e000200. doi: 10.1136/bmjresp-2017-000200. eCollection 2017.

  PMID: 29071075 BACKGROUND

• Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.

  PMID: 29661384 BACKGROUND

Related Links

• Official website of Uijeongbu St. Mary's Hospital, The Catholic University of Korea, the study site for this investigator-initiated single-center randomized clinical trial.

MeSH Terms

Conditions

Postoperative Complications; Pulmonary Atelectasis; Pneumonia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Respiration Disorders

Study Officials

• Jinbeom Cho, MD, PhD

  Department of Surgery, Uijeongbu St. Mary's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbeom Cho, MD, PhD

CONTACT

+821033757470; jinbum21@catholic.ac.kr

Junhyun Lee, MD, PhD

CONTACT

+821090945287; surgeryjun@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)