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A comparison of the new laryngeal mask airway (LMA), LMA-Protector with the LMA-Supreme in surgical patients requiring airway management with an LMA.

Comparison of the LMA-Protector versus the LMA-Supreme on correct fit and positioning in surgical patients requiring LMA airway management.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000783527
Enrollment
100
Registered
2015-07-28
Start date
2015-08-01
Completion date
2016-06-23
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this study we are comparing two laryngeal mask airways (LMAs), a current model which is commonly used with the latest model of the device for flexibility, traumatic effect and ease of optimal positioning. We are performing a randomised controlled study to find out which device performs better in clinical practice. We are randomly selecting people to the groups and giving each a different device. The results will be compared to see if one is better. There is a 50:50 chance of being in one group or the other.

Interventions

The LMA-Protector is a new single-use, silicone, TGA- approved device that has similar features to other LMAs made of PVC. The silicone composition of the LMA-Protector makes it very flexible and the device allows access to and functional separation of the ventilation and digestive tracts with 2 drainage channels. Its use involves insertion under anaesthesia and inflation of the cuff once correct position in the hypopharynx is achieved. Duration of use is from the start of general anaesthesia t

The LMA-Protector is a new single-use, silicone, TGA- approved device that has similar features to other LMAs made of PVC. The silicone composition of the LMA-Protector makes it very flexible and the device allows access to and functional separation of the ventilation and digestive tracts with 2 drainage channels. Its use involves insertion under anaesthesia and inflation of the cuff once correct position in the hypopharynx is achieved. Duration of use is from the start of general anaesthesia to the end of the surgical procedure, and total time is dependent on the surgical procedure. The anaesthetist will administer the intervention and record a log of use time.

Sponsors

Royal Brisbane and Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

American Society of Anesthesiology physical status grade 1-3 and scheduled elective surgery under general anaesthesia.

Exclusion criteria

Patients who are pregnant, at risk of aspiration of gastric contents, requiring surgery in a position other than supine, undergoing head and neck surgery, or need endotracheal intubation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026