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Clinical Trials/NCT02037958
NCT02037958
Completed
Not Applicable

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

Changi General Hospital1 site in 1 country76 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cholecystitis
Sponsor
Changi General Hospital
Enrollment
76
Locations
1
Primary Endpoint
Time to Effective Airway
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
January 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelvin Quek How Yow

Consultant Anaesthetist

Changi General Hospital

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Number of attempts taken for successful placement of airway device(Baseline)
  • Peak airway pressure during pneumoperitoneum(Assessed intra-operatively, during the period of pneumoperitoneum)
  • Incidence of post-operative sore throat(Assessed 1 hr after the surgery, at the Recovery Area)
  • Number of attempts taken for successful placement of gastric tube(Baseline)
  • Haemodynamic response to insertion of airway device(Baseline, 1 min, 5 min)

Study Sites (1)

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