Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy
- Conditions
- Laparoscopic Surgery
- Interventions
- Device: BASKA maskDevice: Endotracheal intubation
- Registration Number
- NCT03045835
- Lead Sponsor
- University of Malaya
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age 18 to 75 years old
- American Society of Anesthesiologists (ASA) physical status I and II BMI ≤ 35
- Laparoscopic cholecystectomy only
- Known gastroesophageal reflux
- History of difficult intubation or difficult anaesthesia
- Features of facial, laryngeal and pharyngeal anatomy problem
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BASKA mask BASKA mask Selection of size : size 3 (30-50kg), size 4 (50-70kg), size 5 (70-100kg) Endotracheal intubation Endotracheal intubation Selection of size : ID 7.0-7.5mm (women), ID 7.5-8.0mm (men)
- Primary Outcome Measures
Name Time Method Time to effective airway insertion 1 hour 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
- Secondary Outcome Measures
Name Time Method Gastric distension scoring by surgeon during operative duration 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
Post operation incidence of complications from the induction of anaesthesia, until at the postanaesthetic care unit (PACU), assessed up to 24 hours 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
Numbers of attempt of airway device insertion and Ease of insertion 1 hour 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
Hemodynamic changes after induction of anaesthesia at 1, 2, 3,4,5,10,20,30 minutes; then post extubation at 1 ,2,3,4,5 minutes Blood pressure and Heart rate
Trial Locations
- Locations (1)
University Malaya Medical Centre
🇲🇾Petaling Jaya, Selangor, Malaysia