- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037958
Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy
January 15, 2014 updated by: Kelvin Quek How Yow, Changi General Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore, 529889
- Changi General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laryngeal Mask Airway-Supreme
Patients who are randomly assigned to receive the LMA-Supreme
|
Patients who receive the LMA-S
Other Names:
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Active Comparator: Endotracheal Tube
Patients who are randomly assigned to receive endotracheal intubation
|
Patients who receive endotracheal intubation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline, 1 min, 5 min
|
Peak airway pressure during pneumoperitoneum
Time Frame: Assessed intra-operatively, during the period of pneumoperitoneum
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Peak airway pressure recorded during pneumoperitoneum, measured during the surgery
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Assessed intra-operatively, during the period of pneumoperitoneum
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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.
|
Assessed 1 hr after the surgery, at the Recovery Area
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kelvin Quek, MMED (Anaes), Changi General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
January 14, 2014
First Submitted That Met QC Criteria
January 15, 2014
First Posted (Estimate)
January 16, 2014
Study Record Updates
Last Update Posted (Estimate)
January 16, 2014
Last Update Submitted That Met QC Criteria
January 15, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGHLMAS2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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