Baska ® Mask Versus Endotracheal Tube in Laparoscopic Cholecystectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03045835|
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Laparoscopic Surgery||Device: BASKA mask Device: Endotracheal intubation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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
- 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
- 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
- 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
- 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
- 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)
- 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)
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
|Contact: CHING CHOE NG, Dr, MMED(ANAES)||+firstname.lastname@example.org|
|Contact: CHEW YIN WANG, Professor Dato' Dr, FRCAemail@example.com|
|Principal Investigator:||CHING CHOE NG, MMED(ANAES)||UNIVERSITY OF MALAYA MEDICAL CENTRE|