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

Tanta University

Status: Enrolling

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

Treatments: Device: Ambu Auragain; Device: I-gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06853756

36264MS287/8/23

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Ambu Auragain group

Experimental group

Description:

Ambu Auragain was inserted after induction.

Treatment:

Device: Ambu Auragain

I-gel group

Experimental group

Description:

The I-gel device was inserted after induction.

Treatment:

Device: I-gel