Failed or Difficult Intubation (Anaesthesia Complications) Clinical Trial
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
| NCT number | NCT02226211 |
| Other study ID # | N-46-2014 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | August 22, 2014 |
| Last updated | August 26, 2014 |
| Start date | June 2014 |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Egypt | faculty of Medicine - Cairo university | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Yes | |
| Secondary | 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. | Yes | |
| Secondary | 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. | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes |