Children requiring gastrointestinal endoscopy, such as those with chronic gastritis or undergoing evaluation for unexplained abdominal pain.
Conditions
Interventions
Intervention group:Gastrointestinal endoscopy-specific laryngeal mask airway
Control group:EtCO?-sampling nasal cannula
Sponsors
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Aged 2–12 years, with prespecified age stratification of 2–6 years and 7–12 years. 2.American Society of Anesthesiologists (ASA) physical status I–III. 3.Scheduled to undergo elective painless combined gastroscopy and colonoscopy. 4.Written informed consent obtained from the legal guardian. 5.Age- and cognition-appropriate assent obtained from the child, where applicable.
Exclusion criteria
Exclusion criteria: 1. Known or suspected difficult airway, including any of the following: a. Main airway obstruction >70%. b. Mallampati class >=III. c. Other anatomical abnormalities that may interfere with airway management. d. History of laryngomalacia. 2. Active respiratory disease, including any of the following: a. Obstructive sleep apnea with an apnea–hypopnea index >=10. b. Severe obesity, defined as a body mass index z-score >=2.33. c. Active upper respiratory tract infection with significant symptoms. d. History of recurrent airway infections, defined as >=2 episodes within the past 3 months. 3. Hemodynamic instability, defined as heart rate or blood pressure persistently exceeding the age-adjusted normal range by 30%. 4. Severe cardiopulmonary disease, such as congenital heart disease with New York Heart Association functional class III or higher. 5. Use of medications that may affect respiratory drive within 24 hours before the procedure, including benzodiazepines, opioids, or a2-adrenergic receptor agonists. 6. Known allergy to silicone materials. 7. The legal representative is unable to understand or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative ventilation strategy failure rate (composite endpoint); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative serious adverse events;Total propofol consumption and dose intensity;Incidence of intraoperative hypotension;Gastroscopy procedure duration;Anesthesia recovery time;First-attempt success rate of airway device placement;Endoscopic field clarity;Incidence of adverse events within 24 hours post-procedure;Incidence of aspiration events;Delayed adverse events at postoperative Day 3 and Day 7;Operator satisfaction scores;Incremental cost-effectiveness ratio (ICER) per averted ventilation failure; | — |
Countries
China
Contacts
Public ContactBilian Li
Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Outcome results
None listed