A comparative trial of a new disposable laryngeal mask airway (LMA® SupremeTM) during anaesthesia in spontaneously breathing adult patients

Phase 4

• Conditions: Supralaryngeal device in spontaneuosly breathing patients; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12608000240347
• Lead Sponsor: Investigator Initiated (Daryl Williams)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Adult undergoing spontaneous ventilation general anaesthesia in whom a supraglottic airway device would have been chosen for maintenance of airway patency by the Anaesthetist responsible for the individual patient.

Exclusion Criteria

Individuals undergoing general anaesthesia in whom it would not have been appropriate to insert a supraglottic airway device for airway patency as determined by the anaesthetist responsible for that patient will be excluded. Such patients include:· Patients with morbid obesity (Body Mass Index 35 kg/m2)· Risk of aspiration· Limited interincisor distance (2.5 cm)· Known difficult airway.Patients who are unable to communicate in English, because of a language barrier, cognitive deficit or intellectual disability will not be approached.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Airway pressure leading to cuff leakage immediately after induction of general anesthesia and placement of LMA, measured in cmH20. The LMAC sealing pressures are between 20-25cmH20. No study to date has directly compared the sealing pressures between the LMAC and other silicone based LMAs. This may have important consequences with the use of these devices in patients where it is considered difficult to maintain a patient airway during general anaesthesia. A standardised amount of air will be injected to achieve cuff inflation pressure of 60cmH20. A manometric stability test (to a maximum pressure of 40 cm H20) will be performed to determine LMA leak pressure.[Immediately after induction of anaesthesia]

Secondary Outcome Measures

Name	Time	Method
Failure to establish an adequate airway (maximum of three attempts, intra-op)[Immediate];First attempt insertion (intra-operative).[Based on observation intraoperatively.];Ease of insertion (intra-operative).[Assessed and reported by the Clinician at the end of the intervention period.];Time to achieve effective airway[intra-operative from induction of anaesthesia to time to achieve effective ventilation];Intra-cuff volume at standardized pressure or maximum intracuff pressure (intra-operative).[Measured at time of inflation of laryngeal mask.];Post-anaesthesia sore throat, hoarse voice and dysphagia in recovery (PACU).[Measured in recovery when the patient is awake and orientated and at 24 hours through question over telephone at 24 hours post-operatively.]