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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| igel | Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the igel second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group. | ||
| Air-Q sp3G | Pediatric patients aged 1-8 years undergoing elective pediatric or urological surgery under general anesthesia. Supraglottic airway (SGA) management will be performed using the Air-Q sp3G second-generation device. Position verification will be performed via fiberoptic bronchoscopy (Grade 3-4 accepted as correct). Gastric volume will be measured with USG pre-insertion, post-insertion, and at surgery completion. Pre-, intra-, and postoperative complications will be documented as in the iGel group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correct SGA Placement Rate via Fiberoptic Bronchoscopy | 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). | Device placement will be assessed intraoperatively |
| Gastric insufflation volume | 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. | gastric volume will be measured intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Airway Pressure | Peak inspiratory airway pressure measured intraoperatively after SGA placement | Intraoperative - immediately after insertion |
| Number of Attempts for Successful SGA Placement |
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Inclusion Criteria:
Exclusion Criteria:
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Children aged 1-8 years (ASA I-III) undergoing elective pediatric surgery under general anesthesia at Ankara Bilkent City Hospital. Eligible participants will require supraglottic airway device placement (i-Gel or Air-Q sp3G).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation | Ankara | Turkey (Türkiye) |
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Count of insertion attempts required to achieve correct SGA positioning
| Intraoperative |
| Postoperative Sore Throat | Incidence of sore throat assessed by direct questioning at 6 hours after surgery. | 6 hours postoperative |
| Postoperative Hoarseness | Incidence of hoarseness assessed by direct questioning at 6 hours after surgery. | 6 hours postoperative |
| Postoperative Dysphagia | Incidence of swallowing difficulty assessed at 6 hours after surgery | 6 hours postoperative |
| Incidence of mucosal bleeding | Incidence of mucosal bleeding assessed by direct questioning at 6 hours after surgery. | 6 hours postoperative |
| Incidence of nausea | Incidence of nausea assessed by direct questioning at 6 hours after surgery | 6 hours postoperative |