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NCT Number: NCT06853756

Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia

Our study aimed to compare the gastric insufflation volume between Ambu AuraGain and i-gel and its relationship with the oropharyngeal sealing pressure and the incidence of postoperative complications in generally anesthetized controlled-ventilated pediatric patients undergoing elective orthopedic operations.

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Key information

Conditions

Gastric Insufflation Ambu AuraGain General Anesthesia I-gel Orthopedic Operations Pediatric

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Aya N Farahat, MBBCH

CONTACT

[email protected]

00201552122249

Kamal E Hikel, MD

SUB_INVESTIGATOR

Maram I Elmazny, MD

SUB_INVESTIGATOR

Shaimaa F Abdelkader, MD

SUB_INVESTIGATOR

About this study

Supraglottic Airway Devices (SADs) refer to a wide range of medical devices that can act as a passageway for oxygenation, ventilation, and administration of anesthetic gases and may be deemed an alternative to Endotracheal Tubes (ETTs).

Oropharyngeal sealing pressure (OLP) provides insight into the risk of gastric insufflation and aspiration risk. It is considered a measure of adequate performance and successful placement based on the premise that the SAD is sited properly in the hypopharynx after blind placements, and it is a useful comparator between SADs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged from 2 to 12 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II.
  • Scheduled for elective orthopedic operations in a supine position under general anesthesia.

Exclusion criteria

  • Patients with a known history of gastro-oesophageal reflux disorders.
  • Full Stomach.
  • Anticipated difficult mask ventilation or intubation.
  • Body mass index "BMI" exceeding 20% of the ideal.
  • A history of chest problems.
  • History of the gastrointestinal tract or thoracic surgeries.

Treatment and study plan

Ambu AuraGain

Device

Ambu Auragain was inserted after induction.

I-gel

Device

The I-gel device was inserted after induction.

Primary outcomes

  1. Gastric antrum cross-sectional area (CSA)

    Time frame: At the end of surgery before supraglottic airway devices removal (5 min)

    Gastric antrum cross-sectional area (CSA) was measured before induction of general anesthesia, before supraglottic airway devices (SAD) insertion, after Ryle's tube insertion, and at the end of surgery before SAD removal.

Secondary outcomes

  1. Oropharyngeal leak pressure

    Time frame: Intraoperatively

    Oropharyngeal leak pressure was determined after confirmation of adequate device insertion and secure taping by closing the adjustable pressure-limiting (APL) valve with a fresh gas flow of 3 l/min and observing the airway pressure at which equilibrium was attained in the aneroid manometer (airway pressure was not allowed to exceed 40cmH2O) or when there was audible air leak from the throat which was auscultated in the neck with a stethoscope placed just beside the thyroid cartilage.

  2. Time of insertion of supraglottic airway devices

    Time frame: Intraoperatively

    Insertion time was measured in seconds and counted from the time of opening the jaw to the appearance of the capnography waveform.

  3. Number of attempts for insertion

    Time frame: Intraoperatively

    Three insertion attempts were allowed. Each 'attempt' was defined as reinsertion of the airway device into the mouth. Insertion failure of the device was defined as greater than three unsuccessful attempts or if the entire process of insertion exceeded 120 seconds.

  4. Incidence of postoperative complications

    Time frame: 24 hours postoperatively

    Incidence of postoperative complications such as mucosal injury, laryngeal spasm, hoarseness, nausea and vomiting were recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya N Farahat, MBBCH

CONTACT

[email protected]

00201552122249

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Gastric Insufflation Volume Using I-gel Versus Ambu AuraGain in Pediatric Patients Undergoing Elective Orthopedic Operations Under General Anesthesia: a Prospective Randomized Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

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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