Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy
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
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 14, 2014
CompletedFirst Posted
Study publicly available on registry
January 16, 2014
CompletedJanuary 16, 2014
January 1, 2014
9 months
January 14, 2014
January 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Effective Airway
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
Baseline
Secondary Outcomes (5)
Number of attempts taken for successful placement of airway device
Baseline
Number of attempts taken for successful placement of gastric tube
Baseline
Haemodynamic response to insertion of airway device
Baseline, 1 min, 5 min
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
Study Arms (2)
Laryngeal Mask Airway-Supreme
EXPERIMENTALPatients who are randomly assigned to receive the LMA-Supreme
Endotracheal Tube
ACTIVE COMPARATORPatients who are randomly assigned to receive endotracheal intubation
Interventions
Patients who receive the LMA-S
Patients who receive endotracheal intubation
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) Physical Status 1 and 2
- Undergoing elective laparoscopic cholecystectomy
You may not qualify if:
- BMI \> 30
- Known gastro-oesophageal reflux disease
- predicted or documented difficult airway
- contraindications to drugs in the standardized anaesthesia protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changi General Hospital
Singapore, Singapore, 529889, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelvin Quek, MMED (Anaes)
Changi General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Anaesthetist
Study Record Dates
First Submitted
January 14, 2014
First Posted
January 16, 2014
Study Start
April 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 16, 2014
Record last verified: 2014-01