Ambu Aura-i Laryngeal Mask Versus Air-Q Intubating Laryngeal Airway for Tracheal Intubation in Adults

Phase 3

• Conditions: Failed or Difficult Intubation (Anaesthesia Complications)
• Interventions: Device: Air-Q intubation laryngeal airway; Device: Ambu-Aura i laryngeal mask

• Registration Number: NCT02226211
• Lead Sponsor: Cairo University

Brief Summary

Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice. they can be used as primary airway devices or as conduits for endoracheal intubation and they become an integral part in the recent guidelines for managing difficult airway.

Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal intubation.

The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage over the competitors but not will studied as a conduit for endoracheal intubation.

This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-08
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-08-26
• Last Update Submitted: 2014-08-26
• Study First Posted: 2014-08-27
• Last Update Posted: 2014-08-27
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients aged from 18-60 years old, ASA I and II and scheduled for elective surgery under general anesthesia

Exclusion Criteria

• history of cardiopulmonary disease, gastro-esophageal reflux disease, abnormal airway anatomy, body mass index > 30 kg.m-2, surgical procedures including head and neck or performed in position other than supine or lithotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
air-Q group	Air-Q intubation laryngeal airway	-
aura-i group	Ambu-Aura i laryngeal mask	-

Primary Outcome Measures

Name	Time	Method
duration of fiberoptic guided insertion of the ETT through the device	duration of induction of general anesthesia, an expected average of 20 minutes. and it is the time span between disconnection of the breathing circuit from the device till reconnection to the ETT and appearance of 1st capnogram wave.

Secondary Outcome Measures

Name	Time	Method
duration of device insertion	duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span between removal of the face mask till device insertion and the chest rise seen after two consecutive positive pressure manual breaths.
Time of device removal	duration of induction of general anesthesia, an expected average of 20 minutes, and it is the time span between disconnection of the breathing circuit from ETT and reconnection to ETT after device removal with appearance of the 1st capnogram wave.
complication during the procedure	average of 20 minutes after induction of general anesthesia, it is the time from removal of face mask, till removal of the device and appearance of the first wave on the capnogram
number of insertion attempts	duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span from removal of face mask till complete insertion or failed third insertion trial of the device
vital sign in form of mean arterial blood pressure, heart rate and oxygen saturation	average of 20 minutes, and it is the time from time of induction of general anesthesia til completion of endotracheal intubation

Trial Locations

Locations (1)

faculty of Medicine - Cairo university; 🇪🇬 Cairo, Egypt