Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation
Ankara, Turkey (Türkiye)
NCT Number: NCT07141498
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.
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Notify Me1 year–8 year
All sexes
Observational
Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 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.
Time frame: Intraoperative - immediately after insertion
Peak inspiratory airway pressure measured intraoperatively after SGA placement
Time frame: Intraoperative
Count of insertion attempts required to achieve correct SGA positioning
Time frame: 6 hours postoperative
Incidence of sore throat assessed by direct questioning at 6 hours after surgery.
Time frame: 6 hours postoperative
Incidence of hoarseness assessed by direct questioning at 6 hours after surgery.
Time frame: 6 hours postoperative
Incidence of swallowing difficulty assessed at 6 hours after surgery
Time frame: 6 hours postoperative
Incidence of mucosal bleeding assessed by direct questioning at 6 hours after surgery.
Time frame: 6 hours postoperative
Incidence of nausea assessed by direct questioning at 6 hours after surgery
Ankara City Hospital Bilkent
Other
Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Device Placement by Fiberoptic Bronchoscopy and Comparison of Gastric Insufflation Volumes Using Ultrasound in Pediatric Patient
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