Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Device: BASKA mask; Device: Endotracheal intubation

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 59100
      • University Malaya Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
oropharyngeal leak pressure (OPL) of the device during operation	the above pressure is measured by performing the maneuver: the expiratory valve of the anaesthetic machine is closed and with a fixed gas flow of 3 L/min, the airway pressure at which equilibrium is reached is recorded. Maximal allowable airway pressure is 40 cm H2O [ OLP is measured at following timeframe - T1: immediately post intubation; T2 : before CO2 insufflation; T3 : after CO2 insufflation; T4 and beyond : each change of position as required during operation (eg. Trendelenburg, reverse Trendelenburg, left tilt)	during operative duration
peak airway pressure of the device during operation	the above pressure is recorded from the anaesthetic machine at following timeframe - T1: immediately post intubation; T2 : before CO2 insufflation; T3 : after CO2 insufflation; T4 and beyond : each change of position as required during operation (eg. Trendelenburg, reverse Trendelenburg, left tilt)	during operative duration

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: CHING CHOE NG, MMED(ANAES), University of Malaya Medical Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (ESTIMATE): February 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy BASKA mask Endotracheal tube
• Other Study ID Numbers: MREC ID NO: 201713-4728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No