Jinbeom cho
Uijeongbu-si, 11765, South Korea
Location contact
Jinbeom Cho, MD, PhD
CONTACT
Jinbeom Cho, MD, PhD
PRINCIPAL_INVESTIGATOR
Junhyun Lee, MD, PhD
CONTACT
Junhyun Lee, MD, PhD
SUB_INVESTIGATOR
NCT Number: NCT07528404
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.
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Not applicable
Uijeongbu-si, 11765, South Korea
Jinbeom Cho, MD, PhD
CONTACT
Jinbeom Cho, MD, PhD
PRINCIPAL_INVESTIGATOR
Junhyun Lee, MD, PhD
CONTACT
Junhyun Lee, MD, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: 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.
Time frame: Within 7 days after surgery
Incidence of postoperative pneumonia occurring within 7 days after surgery, assessed according to predefined criteria in the study protocol.
Time frame: Within 7 days after surgery
Incidence of clinically significant postoperative atelectasis requiring therapeutic intervention within 7 days after surgery, assessed according to predefined criteria in the study protocol.
Time frame: Within 7 days after surgery
Incidence of postoperative respiratory failure within 7 days after surgery, including the need for escalation of respiratory support, as defined in the study protocol.
Time frame: From surgery to hospital discharge (up to 30 days)
Duration of postoperative hospital stay measured from the date of surgery to hospital discharge.
Time frame: From postoperative ICU admission to ICU discharge (up to 30 days)
Duration of postoperative intensive care unit stay measured from ICU admission after surgery to ICU discharge.
Time frame: Within 30 days after surgery
All-cause mortality occurring within 30 days after surgery.
Time frame: Within 30 days after hospital discharge
Hospital readmission for any cause within 30 days after discharge following the index surgery.
Contact information is provided by the study sponsor or research team.
Jinbeom Cho, MD, PhD
CONTACT
Junhyun Lee, MD, PhD
CONTACT
Uijeongbu St. Mary Hospital
Other
High-Flow Nasal Cannula for Prevention of Early Postoperative Pulmonary Complications After Major Abdominal Surgery: A Prospective Single-Center Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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