Brief Title
Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy
Official Title
The Laryngeal Mask Airway Supreme (TM) is an Effective Alternative to Laryngoscope-guided Tracheal Intubation for Patients Undergoing Elective Laparoscopic Cholecystectomy-- A Prospective Randomized Controlled Trial
Brief Summary
We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.
Detailed Description
The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.
Study Type
Interventional
Primary Outcome
Time to Effective Airway
Secondary Outcome
Number of attempts taken for successful placement of airway device
Condition
Cholecystitis
Intervention
Laryngeal Mask Airway-Supreme
Study Arms / Comparison Groups
Laryngeal Mask Airway-Supreme
Description: Patients who are randomly assigned to receive the LMA-Supreme
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
76
Start Date
April 2011
Completion Date
January 2012
Primary Completion Date
January 2012
Eligibility Criteria
Inclusion Criteria: - American Society of Anesthesiologists (ASA) Physical Status 1 and 2 - Undergoing elective laparoscopic cholecystectomy Exclusion Criteria: - BMI > 30 - Known gastro-oesophageal reflux disease - predicted or documented difficult airway - contraindications to drugs in the standardized anaesthesia protocol
Gender
All
Ages
21 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Kelvin Quek, MMED (Anaes), ,
Location Countries
Singapore
Location Countries
Singapore
Administrative Informations
NCT ID
NCT02037958
Organization ID
CGHLMAS2010
Responsible Party
Principal Investigator
Study Sponsor
Changi General Hospital
Study Sponsor
Kelvin Quek, MMED (Anaes), Principal Investigator, Changi General Hospital
Verification Date
January 2014