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A comparison of the AuraGain laryngeal mask with the LMA Supreme - a cross-over study

A comparison of seal pressure and ease of use of the AuraGain laryngeal mask and the LMA Supreme mask in overweight and moderately obese female surgical patients - a crossover study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001089527
Enrollment
52
Registered
2015-10-16
Start date
2015-10-20
Completion date
2016-02-10
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

Comparison of insertion parameters and seal pressures between two types of supraglottic airway devices (breathing devices used for airway management) - an established device called Laryngeal Mask Airway Supreme and a novel device AuraGain Laryngeal Mask, using a cross-over design. Study participants will be females undergoing planned (elective) procedures (gynaecology, all types of general surgery, urology), with Body Mass Index between 25-35 kg/m2, without any additional risk for gastric content regurgitation/aspiration. Study null hypothesis: no differences in the oropharyngeal seal pressures between the AuraGain LM and LMA Supreme.

Interventions

1. Insertion of the AuraGain laryngeal mask a) The AuraGain laryngeal mask is inserted through patient´s mouth and down to the perilaryngeal area (down airway) to keep the airway open during anaesthesia. The cuff at the end of the tube is then inflated to form a seal. The device is kept in place for the duration of surgery. b) time of insertion and time of device removal - the device is inserted at start of general anaesthesia and removed on emergence post surgery. c) the device is inserted by

1. Insertion of the AuraGain laryngeal mask a) The AuraGain laryngeal mask is inserted through patient´s mouth and down to the perilaryngeal area (down airway) to keep the airway open during anaesthesia. The cuff at the end of the tube is then inflated to form a seal. The device is kept in place for the duration of surgery. b) time of insertion and time of device removal - the device is inserted at start of general anaesthesia and removed on emergence post surgery. c) the device is inserted by a doctor with a Board Certification in Anaesthesia - anaesthetist d) approximate duration of the mask in place is five minutes for the first allocated mask, and for second mask the average time is approximately 1 hour, dependent on surgical procedure. e) features differing from the control/comparator mask - broader breathing channel than LMA Supreme, gastric channel is not incorporated in the middle of the breathing tube (such as in the LMA Supreme) but in front of it. 2. Achievement of the cross-over design in the clinical setting. With a patient already under general anaesthesia, patient will have the first allocated mask inserted, with number of attempts and time taken for insertion recorded. The seal pressure will then be recorded and 5 minutes after insertion, the mask will be removed. After a 1 minute washout period, the second mask will be inserted with attempts, timing and seal pressure recorded. This mask will stay in place for the duration of the surgical procedure until emergence from anaesthesia.

Sponsors

General University Hospital (Vseobecna fakultni nemocnice)
Lead SponsorHospital

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

elective surgery - gynaecology, general surgery, urology ASA status 1-4 Body Mass Index 25-35 kg/m2

Exclusion criteria

emergency surgery increased risk for gastric content regurgitation and/or aspiration Body Mass Index (BMI) over 35 kg/m2

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026