Clinical trial NCT02226211: Ambu Aura-i Laryngeal Mask Versus Air-Q Intubating Laryngeal Airway for Tracheal Intubation in Adults
Official title: Ambu® Aura-iTM Laryngeal Mask Versus Air-QTM Intubating Laryngeal Airway as Conduits for Tracheal Intubation in Adults. A Randomized Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Failed or Difficult Intubation (Anaesthesia Complications)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: duration of fiberoptic guided insertion of the ETT through the device
timeFrame: 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 outcomes:
measure: duration of device insertion
timeFrame: 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.
measure: Time of device removal
timeFrame: 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.
measure: number of insertion attempts
timeFrame: 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
measure: complication during the procedure
timeFrame: 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
measure: vital sign in form of mean arterial blood pressure, heart rate and oxygen saturation
timeFrame: average of 20 minutes, and it is the time from time of induction of general anesthesia til completion of endotracheal intubation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of Medicine - Cairo university
Study officials:
References: