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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.
Postoperative pulmonary complications (PPCs) remain an important cause of delayed recovery after major abdominal surgery. Early postoperative respiratory impairment, including atelectasis, impaired oxygenation, secretion retention, and increased respiratory effort, may lead to prolonged hospitalization, escalation of respiratory support, and increased postoperative morbidity. High-flow nasal cannula (HFNC) provides several physiological benefits, including delivery of warmed and humidified oxygen, improved mucociliary clearance, reduction of anatomical dead space, decreased upper airway resistance, and mild positive airway pressure that may help preserve functional residual capacity. Despite these physiological advantages, evidence supporting the routine preventive use of HFNC after major abdominal surgery remains inconclusive.
This study is a prospective, single-center, randomized, controlled, open-label, parallel-group clinical trial designed to evaluate the clinical effectiveness of prophylactic HFNC in adult patients undergoing major abdominal surgery under general anesthesia. Eligible participants are adults aged 19 years or older who undergo protocol-defined major abdominal surgery with an actual anesthetic duration of at least 3 hours and are successfully extubated immediately after surgery. Final eligibility is confirmed after surgery based on the actual surgical procedure performed and the actual anesthetic duration.
After arrival in the post-anesthesia care unit or intensive care unit following extubation, participants will be randomized in a 1:1 ratio to either the HFNC group or the standard postoperative respiratory care group using a centralized web-based randomization system. Randomization will use block randomization with stratification according to surgical approach and surgical category. The HFNC group will receive warmed and humidified high-flow nasal cannula therapy initiated within 30 minutes after arrival and continued for 24 hours in addition to standard postoperative respiratory care. The standard care group will receive conventional postoperative respiratory management, including low-flow oxygen as clinically indicated, deep-breathing and coughing instruction, pain control, early mobilization, respiratory physiotherapy, and secretion clearance support as needed.
The primary outcome is the occurrence of clinically significant postoperative pulmonary complications within 7 postoperative days, assessed using standardized consensus-based definitions. Secondary outcomes include individual respiratory complications, escalation of respiratory support, reintubation, intensive care unit and hospital length of stay, 30-day readmission, 30-day all-cause mortality, and selected postoperative non-pulmonary complications.
This trial is intended to provide high-quality evidence regarding whether short-term prophylactic HFNC during the immediate postoperative period can reduce clinically meaningful pulmonary complications in a clearly defined high-risk population after major abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pneumonia | Incidence of postoperative pneumonia occurring within 7 days after surgery, assessed according to predefined criteria in the study protocol. | Within 7 days after surgery |
| Clinically significant postoperative atelectasis |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinbeom Cho, MD, PhD | Contact | +821033757470 | jinbum21@catholic.ac.kr | |
| Junhyun Lee, MD, PhD | Contact | +821090945287 | surgeryjun@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jinbeom Cho, MD, PhD | Department of Surgery, Uijeongbu St. Mary's Hospital, The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinbeom cho | Uijeongbu-si | 11765 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25058504 | Background | 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. | |
| 33664838 |
| Label | URL |
|---|---|
| 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. | View source |
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Individual participant data (IPD) will not be shared because no formal data-sharing mechanism has been established for this investigator-initiated single-center study, and data access may be limited by institutional and privacy regulations.
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|
| 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. |
|
Incidence of clinically significant postoperative atelectasis requiring therapeutic intervention within 7 days after surgery, assessed according to predefined criteria in the study protocol.
| Within 7 days after surgery |
| Postoperative respiratory failure | Incidence of postoperative respiratory failure within 7 days after surgery, including the need for escalation of respiratory support, as defined in the study protocol. | Within 7 days after surgery |
| Length of postoperative hospital stay | Duration of postoperative hospital stay measured from the date of surgery to hospital discharge. | From surgery to hospital discharge (up to 30 days) |
| Length of postoperative intensive care unit stay | Duration of postoperative intensive care unit stay measured from ICU admission after surgery to ICU discharge. | From postoperative ICU admission to ICU discharge (up to 30 days) |
| All-cause mortality within 30 days after surgery | All-cause mortality occurring within 30 days after surgery. | Within 30 days after surgery |
| Hospital readmission within 30 days after discharge | Hospital readmission for any cause within 30 days after discharge following the index surgery. | Within 30 days after hospital discharge |
| 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. |
| 27771739 | 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. |
| 29071075 | 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. |
| 29661384 | 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. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D001261 | Pulmonary Atelectasis |
| D011014 | Pneumonia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012120 | Respiration Disorders |
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