Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy

Study 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.

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 Controlled Trial

Conditions
-----------------
Cholecystitis, Choledocholithiasis

Intervention / Treatment
-----------------
* Device: Laryngeal Mask Airway-Supreme
* Device: Endotracheal Tube


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laryngeal Mask Airway-Supreme<br>Patients who are randomly assigned to receive the LMA-Supreme | Device: Laryngeal Mask Airway-Supreme<br>* Patients who receive the LMA-S<br>* Other names: LMA Supreme;|
| Active Comparator: Endotracheal Tube<br>Patients who are randomly assigned to receive endotracheal intubation | Device: Endotracheal Tube<br>* Patients who receive endotracheal intubation<br>* Other names: Tracheal Tube;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |