Trial Review

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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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
Scientific title
Evaluate the supraglottic suction efficacy of Suction Enhanced Laryngeal Mask Airway during general anaesthesia for adults having oral or nasal surgery
Secondary ID [1] 312218 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oral surgery under general anaesthesia 333899 0
nasal surgery under general anaesthesia 337369 0
Condition category
Condition code
Surgery 330578 330578 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328664 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338331 0
suction efficacy in clearing oropharyngeal secretions from supraglottic airway
Timepoint [1] 338331 0
At completion of surgery/anaesthesia
Secondary outcome [1] 435454 0
clinician satisfaction
Timepoint [1] 435454 0
at completion of surgery/anaesthesia

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Weight over 150kg
Contraindication to laryngeal mask airway (eg aspiration risk, per accepted and established standards of anaesthetic practice)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
15/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26573 0
St Vincent's Hospital - Toowoomba
Recruitment postcode(s) [1] 42617 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 316595 0
Commercial sector/Industry
Name [1] 316595 0
Medeco Pty Ltd
Country [1] 316595 0
Australia
Funding source category [2] 318890 0
Other Collaborative groups
Name [2] 318890 0
Meditech Asia Pacific Pty Ltd
Country [2] 318890 0
Australia
Funding source category [3] 319074 0
Other Collaborative groups
Name [3] 319074 0
St Vincents hospital
Country [3] 319074 0
Australia
Primary sponsor type
Individual
Name
Dr Alexandra Anderson - Medeco
Address
Country
Australia
Secondary sponsor category [1] 318775 0
Commercial sector/Industry
Name [1] 318775 0
Meditech Systems Asia Pacific
Address [1] 318775 0
Country [1] 318775 0
Australia
Other collaborator category [1] 283515 0
Hospital
Name [1] 283515 0
St Vincents Hospital Toowoomba
Address [1] 283515 0
Country [1] 283515 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315379 0
St Vincent's Health & Aged Care Human Research Ethics Committee
Ethics committee address [1] 315379 0
Ethics committee country [1] 315379 0
Australia
Date submitted for ethics approval [1] 315379 0
01/05/2024
Approval date [1] 315379 0
Ethics approval number [1] 315379 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134522 0
Dr Alexandra Anderson
Address 134522 0
Downs Anaesthetic Practice, Mills Precinct 269 Ruthven Street, Toowoomba, Queensland, 4350
Country 134522 0
Australia
Phone 134522 0
+61 074635246
Fax 134522 0
Email 134522 0
[email protected]
Contact person for public queries
Name 134523 0
Alexandra Anderson
Address 134523 0
Downs Anaesthetic Practice, Mills Precinct 269 Ruthven Street, Toowoomba, Queensland, 4350
Country 134523 0
Australia
Phone 134523 0
+61 074635246
Fax 134523 0
Email 134523 0
[email protected]
Contact person for scientific queries
Name 134524 0
Alexandra Anderson
Address 134524 0
Downs Anaesthetic Practice, Mills Precinct 269 Ruthven Street, Toowoomba, Queensland, 4350
Country 134524 0
Australia
Phone 134524 0
+61 074635246
Fax 134524 0
Email 134524 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?



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.