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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-12
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ambu Auragain

    Device

    Ambu Auragain was inserted after induction.

  • I-gel

    Device

    The I-gel device was inserted after induction.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Ambu Auragain groupExperimental treatment 1 intervention
Group B: I-gel groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gastric antrum cross-sectional area (CSA)

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.

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

Secondary outcomes

1

Oropharyngeal leak pressure

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.

Time frame
Intraoperatively
2

Time of insertion of supraglottic airway devices

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

Time frame
Intraoperatively
3

Number of attempts for insertion

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.

Time frame
Intraoperatively
4

Incidence of postoperative complications

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

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

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