Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001263482
Ethics application status
Approved
Date submitted
10/08/2016
Date registered
8/09/2016
Date last updated
8/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised trial comparing Baska Mask and Supreme Laryngeal Mask Airway in different head and neck positions during elective surgeries involving ASA Class I to III adults
Scientific title
Randomised trial comparing oropharyngeal leak pressures of the Baska Mask and Supreme Laryngeal Mask Airway in different head and neck positions during elective surgeries involving ASA Class I to III adults.
Secondary ID [1] 289917 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway Intervention 299888 0
Condition category
Condition code
Anaesthesiology 299790 299790 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention device: Baska FESS Mask

The Baska Mask 'Registered Trademark' (BM) is a third generation supraglottic airway device. It has many of the features of other supraglottic airways, with a number of innovations. These include a self-sealing membranous, variable-pressure, non-inflatable, recoiling cuff made of medical grade silicone which during positive pressure ventilation, the cuff itself is ‘inflated’ improving the seal, reducing leak and make ventilation more efficient. The BM features gastric reflux high flow suction clearance system consisting of an inlet that fits into the upper oesophagus, and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space. This system allows for rapid clearance of gastric fluids or secretions that may collect in the sump during maintenance and emergence from anesthesia which may reduce the risk of pulmonary aspiration. There is an extended hand-tab for manually curving the mask to facilitate insertion.

The Baska FESS Mask is very useful in ENT apart from its usage in facial and eye surgery. It is designed to be shorter than the standard Baska Mask and is fitted with a curved connector at 120 degree angle so that when in use the device does not interfere with the surgical field and allows the surgeon to operate without interfering with his operating field.

Anaesthesiologists with more than 5 years of experience in using supraglottic airways, but not necessarily the Baska FESS Mask, will perform the supraglottic airway insertions.
The size of the airway will be chosen in accordance with the manufacturers’ recommendations. For the Supreme LMA, a size 3 will be used if < 50 kg, a size 4 if 50–70 kg and a size 5 if 70–100 kg
Size selection of the Baska Fess will be based on the manufacturer’s recommendation of weight-based estimate ( Size 3: 30-50kg, Size 4: 50-70kg, Size 5: 70-100kg) plus clinical judgement. Both the Supreme LMA and the Baska Fess will be prepared and lubricated according to manufacturer’s guidelines.


Anaesthesia will be induced with the patient’s head in the neutral position, resting on a donut head ring approximately 5cm in height. Induction will be with iv fentanyl 1-2mcg/kg and iv propofol 1.5 – 2.5mg/kg and the patient will be maintained with sevoflurane in oxygen. Depth of anaesthesia will be judged as adequate when the patient has loss of eyelash reflex and no response to jaw thrust. If coughing, gagging or movement occurs during insertion, anaesthesia can be deepened with further boluses of iv propofol 0.5mg/kg.

After insertion, the cuff of the LMA Supreme will be inflated with air to attain a cuff pressure of 60 cmH2O as measured with a handheld aneroid manometer. The Baska Fess mask does not need inflation of the cuff.

The different head and neck positions being investigated include the supine position, 30 degrees neck flexion, 45 degrees neck extension, 45 degrees lateral rotation to one side determined by a goniometer.

Intervention code [1] 295599 0
Treatment: Devices
Comparator / control treatment
Laryngeal Mask Airway Supreme 'Registered Trademark'
LMA Supreme 'Registered Trademark' is a single use, second generation, gastric access device which forms an effective First Seal 'Registered Trademark' with the oropharynx (oropharyngeal seal) and an innovative Second Seal 'Registered Trademark' with the upper oesophageal sphincter (the oesophageal seal).
Control group
Active

Outcomes
Primary outcome [1] 299255 0
Oropharyngeal leak pressure of the Baska Fess as compared to the Supreme LMA in different head and neck positions which will be measured using an aneroid manometer
Timepoint [1] 299255 0
Immediately after successful insertion of the randomised airway device prior to the start of surgery
Secondary outcome [1] 326657 0
To compare the performance of the Baska Mask and the Supreme Laryngeal Mask Airway in terms of number of attempts at insertion.

Three insertion attempts were allowed. Successful establishment of effective ventilation was determined by the appearance of the first square end-tidal carbon dioxide (ETCO2) trace. Otherwise, the device was completely removed for another insertion attempt. Each “attempt” was defined as re-insertion of the SGA into the mouth. When insertion attempts more than three times or the entire process of insertion exceeded 120 seconds, it was considered as insertion failure. In case of failure of both devices, the airway was secured according to the decision of the attending anaesthesiologist.
Timepoint [1] 326657 0
Immediately after successful insertion of the randomised airway device prior to the start of surgery
Secondary outcome [2] 327015 0
To compare the performance of the Baska Mask and the Supreme Laryngeal Mask Airway in terms of the ease of insertion of airway device

Will be graded as easy, difficult, impossible
Timepoint [2] 327015 0
Immediately after successful insertion of the randomised airway device prior to the start of surgery
Secondary outcome [3] 327016 0
To compare the performance of the Baska Mask and the Supreme Laryngeal Mask Airway in terms of time taken for insertion of airway device

A stopwatch will be used to determine the time taken from the point the airway device comes into contact with the patient's lip to successful insertion of the airway device determined by establishment of effective ventilation via a capnogram trace.
Timepoint [3] 327016 0
Immediately after successful insertion of the randomised airway device prior to the start of surgery
Secondary outcome [4] 327019 0
To compare the performance of the Baska Mask and the Supreme Laryngeal Mask Airway in terms of fibreoptically determined laryngeal view grade.

This is graded from 1 to 4 using the score developed by Brimacombe and Berry: Grade 1, vocal cords not seen; Grade 2, vocal cords and anterior (down folded, lingual surface) epiglottis seen; Grade 3, vocal cords and posterior (laryngeal surface) epiglottis seen; Grade 4, only vocal cords seen.
Timepoint [4] 327019 0
Immediately after successful insertion of the randomised airway device prior to the start of surgery

Eligibility
Key inclusion criteria
1. ASA grade I-III
2. Ages 18 – 70
3. Any elective surgeries
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Surgery in the non-supine position
2. Known or predicted difficult airway
3. Morbid obesity with BMI>35kg/m2
4. Any patients deemed by the anaesthetist to be at increased risk of gastric aspiration (such as inadequate fasting time, pregnancy, expected operation time >3 hours, upper gastrointestional tract surgery, hiatus hernia)
5. Patients with active upper respiratory tract infection or pneumonia,
6. Patients with neck injury, at risk for neck instability (such as rheumatoid arthritis or Down’s syndrome) or patients with reduced range of neck movement, and patients with vertebral artery occlusion

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the proposed study, sample size was determined by using power study. This power study was performed using web based sample size calculator (http://www.stat.ubc.ca/~rollin/stats/ssize/n2.html) to determine the sample size. Considering 80% power and 5% marginal error (type one error for a value=0.05), this study gives a minimum sample size of 36 per group (based on the mean and SD of 29.98 +/- 8.51, 24.50 +/- 6.19 from previous similar studies).

One hundred patients will be recruited

Collected data will be entered and analysed using SPSS Statistics Software. Normal distribution of numerical data will be reported in means (SD) while non-normal distribution data will be reported in median (IQR), while categorical data is reported in frequency and percentage.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2016
Actual
Date of last participant enrolment
Anticipated
1/04/2017
Actual
Date of last data collection
Anticipated
2/04/2017
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8091 0
Malaysia
State/province [1] 8091 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 294282 0
University
Name [1] 294282 0
University Malaya
Country [1] 294282 0
Malaysia
Primary sponsor type
Individual
Name
Foo Li Lian
Address
Department of Anaesthesiology.
University Malaya Medical Centre. Lembah Pantai,59100. Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 293116 0
Individual
Name [1] 293116 0
Lee Chong En
Address [1] 293116 0
Department of Anaesthesiology
University Malaya Medical Centre. Lembah Pantai,59100. Kuala Lumpur, Malaysia
Country [1] 293116 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295714 0
University Malaya Medical Center Ethics Committee
Ethics committee address [1] 295714 0
University Malaya Medical Centre. Lembah Pantai,59100. Kuala Lumpur, Malaysia
Ethics committee country [1] 295714 0
Malaysia
Date submitted for ethics approval [1] 295714 0
01/04/2016
Approval date [1] 295714 0
15/06/2016
Ethics approval number [1] 295714 0
20163-2317

Summary
Brief summary
Since the introduction of the classic Laryngeal Mask Airway (LMA) by Dr Archie Brain in 1988, supraglottic airways have gained increasing importance both as a tool for elective airway ventilation as well as an important device in the management of the difficult airway.

Most supraglottic airways consist of a cuff which needs to be inflated with air to achieve a seal. Newer devices such as the LMA Supreme and LMA Proseal incorporate a gastric drainage tube to vent regurgitated secretions. Accurate positioning and adequate pressure and volume within the cuff are fundamental to achieve optimal function.


The Baska 'Registered Trademark' mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. The Baska FESS is a modification of the Baska mask with a connector that can be turned to face south, thereby facilitating surgical access for head and neck procedures. The non-inflatable cuff of the Baska and Baska FESS masks are continuous with the central channel of the mask. As the pressure increases with positive pressure ventilation, the cuff itself is ‘inflated’, which may improve the seal. The dorsal surface of the cuff is moulded to direct oropharyngeal contents towards the side channels to which continuous suction can be attached. These two features may reduce the risk of aspiration of gastric contents.


The oropharyngeal leak pressure, as well as the performance of the Baska mask in different head and neck positions have not been well studied. High oropharyngeal leak pressures are important as they indicate airway protection and feasibility of positive pressure ventilation.

This study will be conducted to investigate the safety and efficacy of the Baska FESS mask, and to compare its performance with the current “gold standard”, the LMA Supreme. As a secondary outcome, we will also evaluate the Baska FESS mask in different head and neck positions and compare it with the LMA Supreme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68202 0
Dr Foo Li Lian
Address 68202 0
University Malaya Medical Centre. Lembah Pantai,59100. Kuala Lumpur, Malaysia
Country 68202 0
Malaysia
Phone 68202 0
+60129889011
Fax 68202 0
Email 68202 0
[email protected]
Contact person for public queries
Name 68203 0
Dr Foo Li Lian
Address 68203 0
University Malaya Medical Centre. Lembah Pantai,59100. Kuala Lumpur, Malaysia
Country 68203 0
Malaysia
Phone 68203 0
+60129889011
Fax 68203 0
Email 68203 0
[email protected]
Contact person for scientific queries
Name 68204 0
Dr Foo Li Lian
Address 68204 0
University Malaya Medical Centre. Lembah Pantai,59100. Kuala Lumpur, Malaysia
Country 68204 0
Malaysia
Phone 68204 0
+60129889011
Fax 68204 0
Email 68204 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized comparison of the Baska FESS mask and the LMA Supreme in different head and neck positions.2018https://dx.doi.org/10.1080/17434440.2018.1506329
N.B. These documents automatically identified may not have been verified by the study sponsor.