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Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03045835
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ng Ching Choe, 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Surgery Device: BASKA mask Device: Endotracheal intubation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy : A Prospective Randomized Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045835


Contacts
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Contact: CHING CHOE NG, Dr, MMED(ANAES) +60379492052 ngcc@ummc.edu.my
Contact: CHEW YIN WANG, Professor Dato' Dr, FRCA +60379492052 wangcy@um.edu.my

Locations
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Malaysia
University Malaya Medical Centre Recruiting
Petaling Jaya, Selangor, Malaysia, 59100
Contact: Ng Ching Choe, MMED,MD    0379393116    ngcc@ummc.edu.my   
Contact: Mohammad Hafizshah bin Sybil Shah, MD    0379493116    hafizshah.sybil@gmail.com   
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: CHING CHOE NG, MMED(ANAES) UNIVERSITY OF MALAYA MEDICAL CENTRE

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Responsible Party: Ng Ching Choe, MD, MMED (Anaes), University of Malaya
ClinicalTrials.gov Identifier: NCT03045835    
Other Study ID Numbers: MREC ID NO: 201713-4728
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ng Ching Choe, University of Malaya:
laparoscopic cholecystectomy BASKA mask Endotracheal tube