Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy

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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