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

NCT ID: NCT06853756

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-03-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ambu Auragain group

Ambu Auragain was inserted after induction.

Group Type EXPERIMENTAL

Ambu Auragain

Intervention Type DEVICE

Ambu Auragain was inserted after induction.

I-gel group

The I-gel device was inserted after induction.

Group Type EXPERIMENTAL

I-gel

Intervention Type DEVICE

The I-gel device was inserted after induction.

Interventions

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Ambu Auragain

Ambu Auragain was inserted after induction.

Intervention Type DEVICE

I-gel

The I-gel device was inserted after induction.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Aya Nabil Farahat

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aya N Farahat, MBBCH

Role: CONTACT

00201552122249

Facility Contacts

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Aya N Farahat, MBBCH

Role: primary

00201552122249

Other Identifiers

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36264MS287/8/23

Identifier Type: -

Identifier Source: org_study_id

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