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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 C

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 Summary: 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.
Sponsor: Changi General Hospital

Current Primary Outcome: Time to Effective Airway [ Time Frame: Baseline ]

Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of attempts taken for successful placement of airway device [ Time Frame: Baseline ]
    Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned
  • Number of attempts taken for successful placement of gastric tube [ Time Frame: Baseline ]
    Number of attempts needed for successful placement of gastric tube. Correct gastric tube placement was determined by positive suctioning of gastric contents or detection of injected air with epigastric auscultation.
  • Haemodynamic response to insertion of airway device [ Time Frame: Baseline, 1 min, 5 min ]
    Systolic blood pressure and heart rate at 0 min, 1 min, 5 min, starting from the time the face mask was removed from the patient's face.
  • Peak airway pressure during pneumoperitoneum [ Time Frame: Assessed intra-operatively, during the period of pneumoperitoneum ]
    Peak airway pressure recorded during pneumoperitoneum, measured during the surgery
  • Incidence of post-operative sore throat [ Time Frame: Assessed 1 hr after the surgery, at the Recovery Area ]
    Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr after the end of surgery. No further follow-up.


Original Secondary Outcome: Same as current

Information By: Changi General Hospital

Dates:
Date Received: January 14, 2014
Date Started: April 2011
Date Completion:
Last Updated: January 15, 2014
Last Verified: January 2014