CompletedPhase 4ACTRN12614000032651

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.


Sponsor

Dr Wendy H.L. Teoh

Enrollment

100 participants

Start Date

May 10, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 21 YearssMax Age: 80 Yearss

Inclusion Criteria1

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

Exclusion Criteria1

  • 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).

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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 inflat

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.


Locations(1)

Singapore

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