Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Baska mask is a new novel supraglottic airway device with many salient features. The investigators aim to determine the benefit of BASKA mask as an effective airway device for laparoscopic surgery, and whether it can even substitute endotracheal intubation, in order to smoothen the surgery and anaesthesia process as well as reduce perioperative complications.

Detailed Description
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Patient's satisfaction and smooth process is crucial for perioperative care.Conduct of Anaesthesia including choice of airway devices play an important role. Endotracheal intubation has long been regarded as the technique of choice for airway management in laparoscopic surgery. However, there is currently an emerging interest in laryngeal mask as the substitute for endotracheal tube in laparoscopic surgery. The increased abdominal pressure secondary to gas insufflation in Laparoscopic surgery demands a good supraglottic airway device with features of good seal, aspiration prevention and effective ventilation. Few studies have evaluated the performance Baska® Mask for various type of surgery and had obtained high first-attempt success rate, easy insertion and a good oropharyngeal leak pressure above 30cmH2O with low complications such as sorethroat, dysphonia and dysphagia. However, study regarding comparison of Baska® mask with endotracheal tube has not been carried out before. Therefore, the investigators would like to evaluate this novel device in comparison with endotracheal tube for laparoscopic surgery in our centre. This will be a prospective randomized controlled study in University Malaya Medical Centre to compare Baska® mask with the conventional laryngoscope-guided endotracheal intubation for laparoscopic surgeries. The investigators would like to study the efficacy of this device in term of : time to effective airway insertion, efficacy of airway seal, post-operation device of complications.

Official Title
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Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy : A Prospective Randomized Trial

Conditions
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Laparoscopic Surgery

Intervention / Treatment
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* Device: BASKA mask
* Device: Endotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years old American Society of Anesthesiologists (ASA) physical status I and II BMI ≤ 35 Laparoscopic cholecystectomy only Exclusion Criteria: Known gastroesophageal reflux History of difficult intubation or difficult anaesthesia Features of facial, laryngeal and pharyngeal anatomy problem

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BASKA mask<br>Selection of size : size 3 (30-50kg), size 4 (50-70kg), size 5 (70-100kg) | Device: BASKA mask<br>* Baska mask will be inserted during induction of anaesthesia and once patient is in an adequate anaesthetic depth<br>|
| Active Comparator: Endotracheal intubation<br>Selection of size : ID 7.0-7.5mm (women), ID 7.5-8.0mm (men) | Device: Endotracheal intubation<br>* Endotracheal intubation will be carried out during induction of anaesthesia and once patient is in an adequate anaesthetic depth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to effective airway insertion | defined as time from picking up the airway device (either BASKA mask or Endotracheal tube), insertion and until occurrence of the first square-waveform capnogram | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of attempt of airway device insertion and Ease of insertion | defined as: 1 - first attempt easy, smooth insertion; 2 - second attempt, insertion with resistance; 3 - three attempts, insertion with difficulty; 4 -failed insertion of the SGAs and need to crossover to ETT group | 1 hour | 
| Gastric distension scoring by surgeon | on a visual analogue scale 0-10 (Figure 2), where 0 = empty stomach, and 10 = heavy distension that interfered with surgical exposure at a) entry of the laparoscope following peritoneal insufflation and b) immediately before removal of the laparoscope at the end of the surgical procedure | during operative duration | 
| Post operation incidence of complications | patients are assessed for the incidence of sore throat, airway trauma (lip, tongue, teeth, blood-staining on device), nausea, vomiting, airway spasm, aspiration, emergence cough | from the induction of anaesthesia, until at the postanaesthetic care unit (PACU), assessed up to 24 hours | 
| Hemodynamic changes | Blood pressure and Heart rate | after induction of anaesthesia at 1, 2, 3,4,5,10,20,30 minutes; then post extubation at 1 ,2,3,4,5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic cholecystectomy BASKA mask Endotracheal tube