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

Ambu® Aura-iTM Laryngeal Mask Versus Air-QTM Intubating Laryngeal Airway as Conduits for Tracheal Intubation in Adults. A Randomized Comparative Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Failed or Difficult Intubation (Anaesthesia Complications)
• Intervention / Treatment: Device: Air-Q intubation laryngeal airway; Device: Ambu-Aura i laryngeal mask

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of medicine - Cairo university
    • Contact: Abeer Ahmed, lecturer; Email: abeer_ahmed@kasralainy.edu.eg
    • Principal Investigator: Abeer Ahmed, lecturer
    • Principal Investigator: Sherif Soaida, lecturer
    • Principal Investigator: Kareem Kamal, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: air-Q group	Device: Air-Q intubation laryngeal airway; The size selection of the air-Q ILA will follow the manufacture guideline to be size 3.5 for females and size 4.5 for males After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations. After successful insertion of the air-Q, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea. After successful intubation, the device will be removed according to the manufactures guides using removal stylet .
Experimental: aura-i group	Device: Ambu-Aura i laryngeal mask; The size selection of the device will follow the manufacture guideline according to the patient weight, size 4 for (50-70kg), size 5 (70-100) and size 6 (> 100kg). After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations. After successful insertion of the aura-i, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea. After successful intubation, the device will be removed according to the manufactures guides using another ETT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): August 27, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: N-46-2014