Comparison of the AMBU Aura-i and LMA Supreme supraglottic airway devices in spontaneously breathing anaesthetised patients

A study comparing the clinical performance and insertion parameters of the AMBU Aura-i and LMA Supreme supraglottic airway devices in spontaneously breathing anaesthetised females undergoing minor gynaeocological procedures.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000032651

Enrollment

100

Registered

2014-01-10

Start date

2012-05-10

Completion date

2012-09-14

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

This trial compared the clinical performance of two supraglottic airway devices (the Ambu Aura-I and LMA Supreme) in 100 spontaneously breathing females undergoing minor surgery under general anaesthesia. Our primary outcome measure was time taken to achieve effective ventilation.

Interventions

After induction of a standard general anaesthetic, the supraglottic airway (Ambu aura-i) was inserted into the patient's mouth and insertion parameters recorded. The amount of the air needed to inflate the cuff was measured. The duration required to insert the airway device will be timed from when the device enters the patient's mouth till the appearance of the first square end-tidal carbon dioxide (ETCO2) trace, therefore denoting successful establishment of effective ventilation. Insertion parameters to be recorded are the device's ease of insertion, number of insertion attempts, oropharyngeal leak pressure, fibreoptic position, and haemodynamic response. These were recorded by an unblinded observer who was not involved in the study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

21 Years to 80 Years

Healthy volunteers

Inclusion criteria

One hundred ASA I- II patients scheduled for elective minor gynaecological and breast procedures in our women's hospital

Exclusion criteria

ASA physical status III or IV; BMI equal to and greater than 40 kg/m2, those with predicted difficult airway; high risk of regurgitation or aspiration; and respiratory tract pathology (including preoperative sore throat).

Outcome results