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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngeal Mask Airway-Supreme | Experimental | Patients who are randomly assigned to receive the LMA-Supreme |
|
| Endotracheal Tube | Active Comparator | Patients who are randomly assigned to receive endotracheal intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal Mask Airway-Supreme | Device | Patients who receive the LMA-S |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts taken for successful placement of airway device | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelvin Quek, MMED (Anaes) | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | Singapore | 529889 | Singapore |
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D003137 | Common Bile Duct Diseases |
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| Endotracheal Tube | Device | Patients who receive endotracheal intubation |
|
|
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 | 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 | Peak airway pressure recorded during pneumoperitoneum, measured during the surgery | Assessed intra-operatively, during the period of pneumoperitoneum |
| Incidence of post-operative sore throat | 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 |
| D001649 | Bile Duct Diseases |
| D002769 | Cholelithiasis |