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Completed

NCT Number: NCT03045835

Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Laparoscopic Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Petaling Jaya, Selangor, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BASKA MASK

Device

Baska mask will be inserted during induction of anaesthesia and once patient is in an adequate anaesthetic depth

Endotracheal intubation

Device

Endotracheal intubation will be carried out during induction of anaesthesia and once patient is in an adequate anaesthetic depth

Primary outcomes

  1. Time to effective airway insertion

    Time frame: 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 outcomes

  1. Numbers of attempt of airway device insertion and Ease of insertion

    Time frame: 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

  2. Gastric distension scoring by surgeon

    Time frame: 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

  3. Post operation incidence of complications

    Time frame: 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

  4. Hemodynamic changes

    Time frame: 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

Other outcomes

  1. oropharyngeal leak pressure (OPL) of the device during operation

    Time frame: during operative duration

    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)

  2. peak airway pressure of the device during operation

    Time frame: during operative duration

    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)

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 8, 2017
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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