Clinical trial NCT03045835: Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy
Official title: Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy : A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: laparoscopic cholecystectomy BASKA mask Endotracheal tube
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to effective airway insertion
timeFrame: 1 hour
Secondary outcomes:
measure: Numbers of attempt of airway device insertion and Ease of insertion
timeFrame: 1 hour
measure: Gastric distension scoring by surgeon
timeFrame: during operative duration
measure: Post operation incidence of complications
timeFrame: from the induction of anaesthesia, until at the postanaesthetic care unit (PACU), assessed up to 24 hours
measure: Hemodynamic changes
timeFrame: after induction of anaesthesia at 1, 2, 3,4,5,10,20,30 minutes; then post extubation at 1 ,2,3,4,5 minutes
Other outcomes:
measure: oropharyngeal leak pressure (OPL) of the device during operation
timeFrame: during operative duration
measure: peak airway pressure of the device during operation
timeFrame: during operative duration
Locations:
city: Petaling Jaya
country: Malaysia
facility: University Malaya Medical Centre
state: Selangor
Study officials:
affiliation: UNIVERSITY OF MALAYA MEDICAL CENTRE
name: CHING CHOE NG, MMED(ANAES)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng CC, Sybil Shah MHB, Chaw SH, Mansor MB, Tan WK, Koong JK, Wang CY. Baska mask versus endotracheal tube in laparoscopic cholecystectomy surgery: a prospective randomized trial. Expert Rev Med Devices. 2021 Feb;18(2):203-210. doi: 10.1080/17434440.2021.1865796. Epub 2020 Dec 31.