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Trial registered on ANZCTR
Registration number
ACTRN12625000569404p
Ethics application status
Submitted, not yet approved
Date submitted
24/05/2024
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Pilot Study for Suction Enhanced Laryngeal Mask Airway (flexible style) used during general anaesthesia.
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Scientific title
Evaluate the supraglottic suction efficacy of Suction Enhanced Laryngeal Mask Airway during general anaesthesia for adults having oral or nasal surgery
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Secondary ID [1]
312218
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
oral surgery under general anaesthesia
333899
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nasal surgery under general anaesthesia
337369
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Condition category
Condition code
Surgery
330578
330578
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Use of suction enhanced laryngeal mask airway
Insertion is by a consultant anaesthetist at induction of anaesthesia which occurs five minutes prior to surgical start time.
Duration of anaesthesia and use of the suction enhanced laryngeal mask airway will be less then two hours
Removal will be either by the consultant anaesthetist in theatre or a qualified recovery nurse in the stage one post anaesthesia care unit.
Strategies to monitor adherence to the intervention will be review of anaesthetic record and data collection form.
The suction enhanced laryngeal mask airway sits in the same position/location in the airway and functions to ventilate the patient in exactly the same way. It differs from the standard laryngeal mask airway in that suction can be applied to the oropharyngeal surface. Suction applied via the Suction Enhanced Laryngeal Mask Airway will be between 80-200mmHg, which is accepted safe levels of suction applied to airways via other devices such as in line suction catheters down endotracheal tubes.
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Intervention code [1]
328664
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Treatment: Devices
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
338331
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suction efficacy in clearing oropharyngeal secretions from supraglottic airway
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Assessment method [1]
338331
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Feedback form
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Timepoint [1]
338331
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At completion of surgery/anaesthesia
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Secondary outcome [1]
435454
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clinician satisfaction
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Assessment method [1]
435454
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feedback form
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Timepoint [1]
435454
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at completion of surgery/anaesthesia
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Eligibility
Key inclusion criteria
Participating patients: adults having oral or nasal surgery under general anaesthesia where the consultant anaesthetist and surgeon are planning to utilise a flexible style LMA product for the airway device.
Inclusion criteria - patient
Patient consent – informed, capable and given freely.
Planned airway management plan for the case is a laryngeal mask airway
Surgery resulting in contamination of airway with blood/secretions (eg dental, oral or nasal surgery)
Inclusion criteria - clinician
1) Consultant anaesthetist, oral and maxillofacial surgeon or ear, nose and throat surgeon
2) qualified recovery nurse for removal of suction enhanced laryngeal mask airway
3) briefed on the trial and consent to participate
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
Weight over 150kg
Contraindication to laryngeal mask airway (eg aspiration risk, per accepted and established standards of anaesthetic practice)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Qualitative pilot study - clinician feedback will be most useful part of data, statistical analysis will be limited to percentage of cases were clinicians deemed effective.
Number of participants was not statistically derived, rather reflects the number of cases the investigators assess the clinicians need to assess efficacy of suction enhanced laryngeal mask airway.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last participant enrolment
Anticipated
29/08/2025
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Actual
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Date of last data collection
Anticipated
15/09/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
26573
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St Vincent's Hospital - Toowoomba
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Recruitment postcode(s) [1]
42617
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4350 - Toowoomba
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Funding & Sponsors
Funding source category [1]
316595
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Commercial sector/Industry
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Name [1]
316595
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Medeco Pty Ltd
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Address [1]
316595
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Country [1]
316595
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Australia
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Funding source category [2]
318890
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Other Collaborative groups
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Name [2]
318890
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Meditech Asia Pacific Pty Ltd
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Address [2]
318890
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Country [2]
318890
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Australia
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Funding source category [3]
319074
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Other Collaborative groups
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Name [3]
319074
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St Vincents hospital
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Address [3]
319074
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Country [3]
319074
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Australia
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Primary sponsor type
Individual
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Name
Dr Alexandra Anderson - Medeco
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Address
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Country
Australia
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Secondary sponsor category [1]
318775
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Commercial sector/Industry
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Name [1]
318775
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Meditech Systems Asia Pacific
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Address [1]
318775
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Country [1]
318775
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Australia
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Other collaborator category [1]
283515
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Hospital
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Name [1]
283515
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St Vincents Hospital Toowoomba
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Address [1]
283515
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Country [1]
283515
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315379
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St Vincent's Health & Aged Care Human Research Ethics Committee
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Ethics committee address [1]
315379
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https://www.svph.org.au/research
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Ethics committee country [1]
315379
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Australia
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Date submitted for ethics approval [1]
315379
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01/05/2024
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Approval date [1]
315379
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Ethics approval number [1]
315379
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Summary
Brief summary
The research is to check the improved safety features of a modified airway device called a laryngeal mask airway. The modification to the device is suction enhancement to allow for suction of secretions and blood that usually collect to the upper (supraglottic) surface of the airway device during oral and nose surgery. Suction of the blood and secretions is anticipated to result in improved patient safety.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
134522
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Dr Alexandra Anderson
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Address
134522
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Downs Anaesthetic Practice, Mills Precinct 269 Ruthven Street, Toowoomba, Queensland, 4350
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Country
134522
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Australia
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Phone
134522
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+61 074635246
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Fax
134522
0
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Email
134522
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[email protected]
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Contact person for public queries
Name
134523
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Alexandra Anderson
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Address
134523
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Downs Anaesthetic Practice, Mills Precinct 269 Ruthven Street, Toowoomba, Queensland, 4350
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Country
134523
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Australia
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Phone
134523
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+61 074635246
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Fax
134523
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Email
134523
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[email protected]
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Contact person for scientific queries
Name
134524
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Alexandra Anderson
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Address
134524
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Downs Anaesthetic Practice, Mills Precinct 269 Ruthven Street, Toowoomba, Queensland, 4350
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Country
134524
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Australia
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Phone
134524
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+61 074635246
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Fax
134524
0
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Email
134524
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
5 PARTICIPANT CONSENT FORM SELMA Flexible pilot study.docx
Other
4 Participant Information Sheet SELMA flexible PILOT STUDY.docx
Study protocol
2 Project Description- flexible SELMA pilot study.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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