High-Flow Nasal Cannula After Major Abdominal Surgery to Prevent Postoperative Pulmonary Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUijeongbu St. Mary Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older.
Undergoing major abdominal surgery under general anesthesia.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
High flow nasal cannula (HFNC)
DeviceHigh-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
Other interventionStandard 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.
Treatment groups
580 Participants
are divided into 2 treatment groupsGroup A: HFNC groupExperimental treatment 1 intervention
Group B: Standard oxygen groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Within 7 days after surgerySecondary outcomes
1
Postoperative pneumonia
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 surgery2
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.
Time frame
Within 7 days after surgery3
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.
Time frame
Within 7 days after surgery4
Length of postoperative hospital stay
Duration of postoperative hospital stay measured from the date of surgery to hospital discharge.
Time frame
From surgery to hospital discharge (up to 30 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: