Placement of LMA Supreme versus GuardianCPV – a randomized controlled trial assessing leak pressure, cuff pressure and fibreoptic grading of airway placement.

In adult surgical patients, comparing LMA Supreme with GuardianCPV with respect to leak pressure, cuff pressure and fibreoptic grading of airway placement.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000365965

Acronym

PLSG

Enrollment

Registered

2011-04-08

Start date

2011-06-01

Completion date

Unknown

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

The research project aims to compare 2 different Laryngeal Mask Airways, and to establish which is superior of the two. The main interest of our trial is to determine which LMA is easier to insert properly, and how well they both maintain a good seal. To date we have seen that there is occasionally some difficulty in placing the LMA, with consequent suboptimal airway control. Device manufacturers are always presenting us with new and improved versions of these devices, and we feel that it is the place of research projects such as this to help us decide if the new devices are worth employing. This sort of research may also aid in the development of future airway devices, leading to safer delivery of anaesthesia to the community. 80 patients will be enrolled in this project which will only be run at the Princess Alexandra Hospital. All patients enrolled in this project will have either one of these “LMAs” inserted after the anaesthetic has started. We will only be trialing 2 types of “LMA”, namely the LMA Supreme and the GuardianCPV, as previously mentioned. All the researchers involved will be from the Princess Alexandra Hospital. This research will be used by the principal researcher Dr Colin Brodie (currently in training in the specialty of anaesthesia) as part of a requirement of his training to become a specialist anaesthetist. This project is not funded by any sponsorship or grant, and all funding for this project will come from the Anaesthetic Department at the Princess Alexandra Hospital.

Interventions

Laryngeal Mask Airways (LMAs) are airway devices that are placed in the pharynx for the duration of an anaesthetic. The duration of anaesthetic differs on a case by case basis, as demanded by the surgical procedure. This is a one-off treatment for a specified surgical procedure. The research project aims to compare 2 different LMA devices – one of which we use on a daily basis (the LMA Supreme), and the other is a newly released LMA (the GuardianCPV) which claims certain benefits. The guardianC

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Healthy volunteers

Yes

Inclusion criteria

Adult patients undergoing elective surgery with an LMA

Exclusion criteria

Patients requiring intubation Women who are pregnant and the human foetus Children and/or young people (ie. <18 years) People in existing dependent or unequal relationships People highly dependent on medical care People with a cognitive impairment, an intellectual disability or a mental illness People who may be involved in illegal activity

Outcome results