Skip to content

High-flow nasal cannula oxygenation versus face-mask positive pressure ventilation for gastric insufflation during pediatric anesthesia induction

Effect of High-Flow Nasal Cannula Oxygenation versus Face-Mask Positive Pressure Ventilation on Gastric Antral Cross-Sectional Area During Pediatric Anesthesia Induction: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125186
Enrollment
Unknown
Registered
2026-05-22
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric insufflation and perioperative aspiration risk during pediatric anesthesia induction

Interventions

HFNC group:During anesthesia induction, high-flow nasal cannula oxygenation (HFNC) will be used without face-mask assisted ventilation. The flow rate will be set according to body weight: 2 L/kg/min f
and 2 L/kg/min for children weighing >15–30 kg, up to 30 L/min. FiO2 will be set at 1.0 with heated humidification. Rescue procedures will be initiated immediately if hypoxemia or inadequate ventilati
Face-mask positive pressure ventilation group:Face-mask positive pressure ventilation will be applied during anesthesia induction. FiO2 will be set at 1.0. Manual positive-pressure face-mask ventilati

Sponsors

Huadu District People’s Hospital of Guangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children scheduled for elective surgery under general anesthesia requiring endotracheal intubation; 2. ASA physical status I–II; 3. Age 2 to =2 h, milk/formula/light meal >=6 h, and solid food >=8 h; 5. Feasible to complete gastric antral ultrasound assessment in both the supine and right lateral decubitus positions during anesthesia induction; 6. Written informed consent obtained from the legal guardian.

Exclusion criteria

Exclusion criteria: 1. Known or suspected delayed gastric emptying, gastrointestinal obstruction, or conditions significantly increasing aspiration risk, such as severe gastroesophageal reflux, pyloric obstruction/stenosis, or gastrointestinal bleeding; 2. Emergency surgery or non-fasting/non-compliance with fasting requirements; 3. Anticipated difficult airway or need for rapid sequence induction (RSI); 4. Severe cardiopulmonary disease or baseline SpO2 <95% on room air or routine oxygen supplementation; 5. Inability to tolerate HFNC or face-mask ventilation, such as severe nasal obstruction/deformity or recent nasal surgery, or deemed unsuitable by the investigator; 6. Failure to obtain interpretable gastric ultrasound images in the supine or right lateral decubitus position, such as poor visualization of the antrum due to bowel gas or positioning limitations; 7. Refusal or withdrawal of consent by the legal guardian.

Design outcomes

Primary

MeasureTime frame
Change in gastric antral cross-sectional area in the right lateral decubitus position (?CSAa-RLD);

Secondary

MeasureTime frame
Change in gastric antral cross-sectional area in the supine position (?CSAa-supine);Change in gastric volume grade;Predicted gastric volume and body weight-adjusted predicted gastric volume;Hypoxemia and need for rescue intervention;Incidence of regurgitation/aspiration;Incidence of postoperative nasal dryness, epistaxis, and postoperative nausea and vomiting;

Countries

China

Contacts

Public ContactNing Shen

Huadu District People’s Hospital of Guangzhou

paulshenyh@163.com+86 139 2228 9000

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026