Elective Surgeries, Fiberoptic Bronchoscopy (FOB), Gastric Insufflation, Gastric Ultrasound, Laryngeal Mask Airways
Conditions
Keywords
laryngeal mask, airway management, ultrasonography, child
Brief summary
This single-center, prospective, randomized controlled study aims to compare the placement accuracy of iGel and Air-Q sp3G supraglottic airway (SGA) devices in pediatric patients aged 1-8 years undergoing elective surgery under general anesthesia. Placement will be confirmed via fiberoptic bronchoscopy, and gastric insufflation will be assessed using ultrasound measurement of gastric antral cross-sectional area pre- and post-device placement. Secondary outcomes include postoperative complications such as sore throat, hoarseness and dysphagia.
Detailed description
This single-center, prospective, randomized controlled trial will be conducted in pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Participants will be randomized into two groups to receive either an iGel or an Air-Q sp3G device. Device placement will be confirmed intraoperatively via fiberoptic bronchoscopy using a standardized grading system and gastric antral cross-sectional area will be measured with ultrasound before device insertion, immediately after insertion and at the end of surgery to evaluate gastric insufflation. Secondary outcomes will include postoperative complications such as sore throat, hoarseness, dysphagia, mucosal bleeding, cough, laryngospasm, bronchospasm, nausea, vomiting and stridor. Intraoperative variables such as number of insertion attempts, ease of placement and peak airway pressure will also be recorded. The results are expected to identify which device offers better placement accuracy and lower gastric insufflation rates, thereby improving perioperative safety and postoperative recovery in pediatric patients.
Interventions
None listed
Sponsors
Ankara City Hospital Bilkent
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 1-8 years * ASA I-III * Elective pediatric or urological surgery under general anesthesia with SGA use * Informed consent obtained from parents/guardians
Exclusion criteria
* Parental refusal or inability to consent * ASA \> III * Recent or current upper respiratory tract infection * History of difficult airway * Increased aspiration risk * Urgent/emergency surgery or non-fasted patients * Known allergy or contraindication to anesthetic agents * Severe asthma (attack within last 6 months) * Structural airway anomalies * Gastrointestinal pathology affecting stomach emptying * Previous stomach surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct SGA Placement Rate via Fiberoptic Bronchoscopy | Device placement will be assessed intraoperatively | In pediatric patients undergoing elective surgery under general anesthesia, the correct placement of supraglottic airway devices (iGel vs. Air-Q sp3G) will be assessed using fiberoptic bronchoscopy grading (Grade 3-4 considered correct positioning). |
| Gastric insufflation volume | gastric volume will be measured intraoperatively | Gastric volume will be measured by ultrasound (USG) at three time points: Baseline (pre-induction): After IV induction, in supine position, before SGA insertion. Post-SGA insertion: Immediately after supraglottic airway (i-Gel or Air-Q sp3G) placement. End of surgery: Before emergence from anesthesia. The change in gastric volume across these time points will be compared between i-Gel and Air-Q sp3G groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Airway Pressure | Intraoperative - immediately after insertion | Peak inspiratory airway pressure measured intraoperatively after SGA placement |
| Number of Attempts for Successful SGA Placement | Intraoperative | Count of insertion attempts required to achieve correct SGA positioning |
| Postoperative Sore Throat | 6 hours postoperative | Incidence of sore throat assessed by direct questioning at 6 hours after surgery. |
| Postoperative Hoarseness | 6 hours postoperative | Incidence of hoarseness assessed by direct questioning at 6 hours after surgery. |
| Postoperative Dysphagia | 6 hours postoperative | Incidence of swallowing difficulty assessed at 6 hours after surgery |
| Incidence of mucosal bleeding | 6 hours postoperative | Incidence of mucosal bleeding assessed by direct questioning at 6 hours after surgery. |
| Incidence of nausea | 6 hours postoperative | Incidence of nausea assessed by direct questioning at 6 hours after surgery |
Countries
Turkey (Türkiye)
Outcome results
None listed