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NCT Number: NCT07141498

Fiberoptic Evaluation of i-Gel and Air-Q sp3G Supraglottic Airway Devices in Pediatric Patients

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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Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correct SGA Placement Rate via Fiberoptic Bronchoscopy

    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).

  2. Gastric insufflation volume

    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.

Secondary outcomes

  1. Peak Airway Pressure

    Time frame: Intraoperative - immediately after insertion

    Peak inspiratory airway pressure measured intraoperatively after SGA placement

  2. Number of Attempts for Successful SGA Placement

    Time frame: Intraoperative

    Count of insertion attempts required to achieve correct SGA positioning

  3. Postoperative Sore Throat

    Time frame: 6 hours postoperative

    Incidence of sore throat assessed by direct questioning at 6 hours after surgery.

  4. Postoperative Hoarseness

    Time frame: 6 hours postoperative

    Incidence of hoarseness assessed by direct questioning at 6 hours after surgery.

  5. Postoperative Dysphagia

    Time frame: 6 hours postoperative

    Incidence of swallowing difficulty assessed at 6 hours after surgery

  6. Incidence of mucosal bleeding

    Time frame: 6 hours postoperative

    Incidence of mucosal bleeding assessed by direct questioning at 6 hours after surgery.

  7. Incidence of nausea

    Time frame: 6 hours postoperative

    Incidence of nausea assessed by direct questioning at 6 hours after surgery

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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