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

NCT06853756 | Recruiting

• 1 other identifier: 36264MS287/8/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

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.

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

Secondary Outcomes (4)

• Oropharyngeal leak pressure

  Intraoperatively

• Time of insertion of supraglottic airway devices

  Intraoperatively

• Number of attempts for insertion

  Intraoperatively

• Incidence of postoperative complications

  24 hours postoperatively

Study Arms (2)

Ambu Auragain group

EXPERIMENTAL

Ambu Auragain was inserted after induction.

Device: Ambu Auragain

I-gel group

EXPERIMENTAL

The I-gel device was inserted after induction.

Device: I-gel

Interventions

Ambu Auragain DEVICE

Ambu Auragain was inserted after induction.

Ambu Auragain group

I-gel DEVICE

The I-gel device was inserted after induction.

I-gel group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Aya N Farahat, MBBCH

CONTACT

00201552122249; aya.nabil311.nabil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: August 1, 2023
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)