Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-03-31

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.

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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.

Conditions

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Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BASKA mask

Selection of size : size 3 (30-50kg), size 4 (50-70kg), size 5 (70-100kg)

Group Type EXPERIMENTAL

BASKA mask

Intervention Type DEVICE

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

Endotracheal intubation

Selection of size : ID 7.0-7.5mm (women), ID 7.5-8.0mm (men)

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

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

Interventions

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BASKA mask

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

Intervention Type DEVICE

Endotracheal intubation

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No