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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02226211 |
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Date of registration:
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22/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ambu Aura-i Laryngeal Mask Versus Air-Q Intubating Laryngeal Airway for Tracheal Intubation in Adults
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Scientific title:
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Ambu® Aura-iTM Laryngeal Mask Versus Air-QTM Intubating Laryngeal Airway as Conduits for Tracheal Intubation in Adults. A Randomized Comparative Clinical Trial |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02226211 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Abeer Ahmed, lecturer |
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Address:
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Telephone:
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Email:
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abeer_ahmed@kasralainy.edu.eg |
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Affiliation:
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Name:
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Abeer Ahmed, lecturer |
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Address:
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Telephone:
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Email:
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abeer_ahmed@kasralainy.edu.eg |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Failed or Difficult Intubation (Anaesthesia Complications)
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Intervention(s)
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Device: Ambu-Aura i laryngeal mask
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Device: Air-Q intubation laryngeal airway
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Primary Outcome(s)
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duration of fiberoptic guided insertion of the ETT through the device
[Time Frame: 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.]
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Secondary Outcome(s)
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complication during the procedure
[Time Frame: 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]
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duration of device insertion
[Time Frame: 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.]
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number of insertion attempts
[Time Frame: 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]
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vital sign in form of mean arterial blood pressure, heart rate and oxygen saturation
[Time Frame: average of 20 minutes, and it is the time from time of induction of general anesthesia til completion of endotracheal intubation]
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Time of device removal
[Time Frame: 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.]
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Secondary ID(s)
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N-46-2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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