A randomized, single-blind controlled trial is currently underway at a tertiary teaching hospital to evaluate the efficacy of high-flow nasal cannula (HFNC) compared to conventional oxygen therapy (COT) in preventing post-anesthesia hypoxemia in infants undergoing non-cardiac surgery. The study, registered at https://www.chictr.org.cn (ChiCTR2400081600), aims to determine if prophylactic use of HFNC can reduce the incidence of desaturation and other respiratory complications in this vulnerable patient population.
The trial, approved by the Institutional Review Board of Chengdu Women’s and Children’s Central Hospital, will enroll 394 infants under 12 months of age undergoing elective non-cardiac surgery. Participants will be randomized in a 1:1 ratio to receive either COT or HFNC post-extubation. The primary outcome is the rate of desaturation, defined as SpO2 < 95% after extubation. Secondary outcomes include the incidence of mild upper airway obstruction, severe respiratory depression, transfer to the Pediatric Intensive Care Unit (PICU), duration of oxygen therapy, length of stay in the post-anesthesia care unit (PACU), time to reach full enteral feeding, and postoperative adverse events such as nasal injury, agitation, vomiting, and unplanned secondary surgery.
Study Design and Methods
Infants meeting specific inclusion criteria, including ASA physical status I-II and requiring general anesthesia with endotracheal intubation, are eligible for enrollment. Exclusion criteria include cardiac, hepatic, or renal dysfunction; pre-existing pulmonary conditions; prior intubation; allergic history to anesthetics; SpO2 < 95% before anesthesia; or refusal to participate by guardians. After extubation, infants in the COT group will receive humidified oxygen at 2-5 L/min via nasal cannula, while those in the HFNC group will receive oxygen at 1-2 L/kg/min via HFNC. The target SpO2 in both groups is ≥ 95%.
Potential Benefits of HFNC
Postoperative hypoxemia is a common complication in infants after general anesthesia, with incidence rates ranging from 4% to 57%. Young infants are particularly vulnerable due to factors such as premature lungs and hemodynamic instability. While COT is traditionally used, its limitations in delivering sufficient oxygen supplementation have prompted the exploration of alternative strategies like HFNC. HFNC delivers warm, humidified gas at a higher flow rate than the patient’s inspiratory flow rate, potentially improving oxygenation and reducing respiratory distress.
Data Collection and Analysis
Data collection includes demographic information, intraoperative details, and postoperative measurements of SpO2, heart rate, and mean blood pressure at various time points. The incidence of respiratory complications, need for reintubation or PICU transfer, duration of oxygen therapy, and adverse events will also be recorded. Statistical analysis will be performed using R studio software, version 4.2.2, with a p-value < 0.05 considered statistically significant. Subgroup analysis will be conducted based on postconceptional age.
Implications and Future Directions
If the trial demonstrates the superiority of HFNC over COT in preventing post-anesthesia hypoxemia, it could lead to a change in clinical practice, with HFNC becoming the preferred first-line oxygen therapy for infants following non-cardiac surgery. The results of this study are expected to be available in May 2025.
