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Postoperative ComplicationsNCT07528404

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

A study testing High flow nasal cannula (HFNC) and Standard oxygen therapy in people with Postoperative Complications and Atelectasis, run by Uijeongbu St. Mary Hospital at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
High flow nasal cannula (HFNC) and Standard oxygen therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
580 participants
Where
1 siteSouth Korea
Study dates
1 Jul 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jinbeom Cho, MD, PhD contact

+821033757470

jinbum21@catholic.ac.kr

Junhyun Lee, MD, PhD contact

+821090945287

surgeryjun@catholic.ac.kr

South Korea1 site
  • Jinbeom cho

    Uijeongbu-si, 11765

    Jinbeom Cho, MD, PhD, +821033757470, jinbum21@catholic.ac.kr

    Junhyun Lee, MD, PhD, +8290945287, surgeryjun@catholic.ac.kr

Other trials in South Korea

About this study

Official title: High-Flow Nasal Cannula for Prevention of Early Postoperative Pulmonary Complications After Major Abdominal Surgery: A Prospective Single-Center Randomized Controlled Trial

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.

Read the detailed description

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.

Being tested
High flow nasal cannula (HFNC), Standard oxygen therapy
Keywords
High-flow nasal cannula, HFNC, PPC, Major abdominal surgery, Postoperative respiratory support, Postoperative pulmonary complications, Randomized controlled trial
Medical subject headings
Postoperative Complications, Pulmonary Atelectasis, Pneumonia, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Standard oxygen therapyOther

    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 groups in NCT07528404
Study groupRoleWhat they receive
HFNC groupExperimentalParticipants 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.
Receives: Device: High flow nasal cannula (HFNC)
Standard oxygen groupActive comparatorParticipants 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.
Receives: Other: Standard oxygen therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 7 days after surgery

Secondary outcomes (7)
  1. Postoperative pneumonia

    Incidence of postoperative pneumonia occurring within 7 days after surgery, assessed according to predefined criteria in the study protocol.

    Measured: Within 7 days after surgery

  2. Clinically significant postoperative atelectasis

    Incidence of clinically significant postoperative atelectasis requiring therapeutic intervention within 7 days after surgery, assessed according to predefined criteria in the study protocol.

    Measured: Within 7 days after surgery

  3. 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.

    Measured: Within 7 days after surgery

  4. Length of postoperative hospital stay

    Duration of postoperative hospital stay measured from the date of surgery to hospital discharge.

    Measured: From surgery to hospital discharge (up to 30 days)

  5. Length of postoperative intensive care unit stay

    Duration of postoperative intensive care unit stay measured from ICU admission after surgery to ICU discharge.

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

  6. All-cause mortality within 30 days after surgery

    All-cause mortality occurring within 30 days after surgery.

    Measured: Within 30 days after surgery

  7. Hospital readmission within 30 days after discharge

    Hospital readmission for any cause within 30 days after discharge following the index surgery.

    Measured: Within 30 days after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07528404
Sponsor's protocol ID
UC26DISI0004
Status last verified
Apr 2026
First submitted
7 Apr 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 25058504
  • 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.

    PubMed 33664838
  • 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.

    PubMed 27771739
  • 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.

    PubMed 29071075
  • 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.

    PubMed 29661384

Questions about this trial

What is this clinical trial studying?

A study testing High flow nasal cannula (HFNC) and Standard oxygen therapy in people with Postoperative Complications and Atelectasis, run by Uijeongbu St. Mary Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinbeom Cho, MD, PhD (+821033757470, jinbum21@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pulmonary complications (PPCs) (time frame: Within 7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07528404, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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