Randomised comparison of the Ambu® Laryngeal Mask with the Laryngeal Mask Airway UniqueTM during anaesthesia in spontaneously breathing adult patients

A single-blind randomised phase IV study to evaluate the effectiveness of the AMBU Aura-once disposable Laryngeal Mask against the Laryngeal Mask Airway -unique wih respect to sealing pressure and ease of use for airway maintenance during spontaneous ventilation general anaesthesia

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000429550

Enrollment

100

Registered

2006-10-04

Start date

2006-09-28

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

Randomised trial of two supraglottic airway devices by measuring objective outcomes in spontaneously breathing adult patients. Our hypothesis is that there will be no identifiable difference (null hypothesis).

Interventions

AMBU laryngeal mask over the course of a single general anaesthetic procedure and 24 hrs post-operatively Laryngeal Mask Airway - Unique over the course of a single general anaesthetic procedure and 24 hrs post-operatively

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults who are undergoing general anaesthesia suitable for a LMA.

Exclusion criteria

Recognised non suitability for supraglottic airway usage.

Outcome results