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 ]
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