Status:
COMPLETED
A Randomised Controlled Trial to Compare Two Supraglottic Airway Devices (Ambu AuraGain vs Air Q-3) in Terms of Performance Characteristics.
Lead Sponsor:
University of Malaya
Conditions:
Oropharyngeal Leak Pressure
Supraglottic Airway
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A supraglottic airway device (SAD) functions as a temporary device to maintain the patency of airway during the administration of anaesthesia. The Ambu AuraGain (Ambu, Ballerup, Denmark) is a second g...
Detailed Description
Preoperative assessment, encompassing history taking, physical examination, laboratory investigation, and a comprehensive explanation of the study, will be conducted the day prior to surgery. Patients...
Eligibility Criteria
Inclusion
- Adult patients (age 18 to 65 years) of either sex, who are scheduled for an elective surgery under general anaesthesia
- Patients with ASA physical status of I or II.
Exclusion
- Patients with anticipated difficult airway (Airway Difficulty Score \>8)
- Patients with high risk of aspiration and regurgitation
- Patients with body mass index (BMI) \> 40kg/m2
- Patients who exhibit evidence of upper respiratory tract infection
- Patients with history of radiotherapy to the neck
- Patients who are pregnant
- Patients who are unable or unwilling to consent for the study
- Patients who are mentally challenged and unable to understand the study instructions
- Planned operating time more than 4 hours
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06914453
Start Date
July 26 2024
End Date
January 24 2025
Last Update
April 9 2025
Active Locations (1)
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1
Department of Anaesthesiology, Faculty of Medicine
Kuala Lumpur, Selangor, Malaysia, 50603