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Successful insertion rates of the i-gel supraglottic device compared to the Smiths Soft Seal laryngeal mask airway (LMA) for out-of-hospital cardiac arrest: A randomised controlled trial

In adult patients in out-of-hospital cardiac arrest, does the i-gel supraglottic airway device when compared to the Smiths Soft Seal Laryngeal Mask Airway (LMA) have a higher rate of successful insertion when performed by paramedics?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000472077
Enrollment
100
Registered
2010-06-09
Start date
2010-07-01
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

Paramedic use of supraglottic airway devices is increaing and it is also seen as a life-saving skill, necessary for protecting and maintaining a patients airway and providing a channel for direct oxygen administration. The current rate for successful insertions of supraglottic airway devices by Ambulance Service of NSW paramedics below optimal. The i-gel supraglottic airway device is a new airway style with a non-inflatable cuff and is structured differently to the Smiths Soft Seal (the device currently in use by ASNSW). This theoretically makes it easier to use and may result in a higher rate of successful insertion. We hypothesise that the i-gel, when compared to the Smiths Soft Seal LMA will result in a higher rate of airway placement.

Interventions

The i-gel supraglottic airway device with non-inflatable cuff. The device consists of a cuff made from a thermoplastic elastomer, which is designed to create a non-inflatable anatomical seal of the laryngeal, pharyngeal and perilaryngeal structures. The connecting hard plastic tube performs as a way in which to administer oxygen to the patient in cardiac arrest. It also has an integrated bite block and gastric channel for the insertion of an intragastic tube by which to empty gastric contents.

The i-gel supraglottic airway device with non-inflatable cuff. The device consists of a cuff made from a thermoplastic elastomer, which is designed to create a non-inflatable anatomical seal of the laryngeal, pharyngeal and perilaryngeal structures. The connecting hard plastic tube performs as a way in which to administer oxygen to the patient in cardiac arrest. It also has an integrated bite block and gastric channel for the insertion of an intragastic tube by which to empty gastric contents. The patient will have the i-gel in situ while they are in cardiac arrest, or if an Intensive Care Paramedic becomes available and deems it is appropriate to insert an endotracheal tube. The device is inserted into the oral cavity of patients in cardiac arrest. It is inserted by gliding the device downwards and backwards along the patients hard palate until definitive resistance is felt. The tip of the cuff sits in the oesophageal opening, and the epiglottis blocker prevents the epiglottis from occluding the tracheal opening, so that the aperture of the cuff sits over the the tracheal opening. The differences between the i-gel and the comparator are that the comparator has an inflatable cuff, which requires the extra step of inflation after insertion. This means that it is not as rigid and the tip of the cuff has folded over as it has been inserted, not sitting in the oesophageal opening. A separate bite block is needed and there is no gastric channel to empty stomach contents, so there is a higher risk of aspiration of stomack contents. There is also a position guide on the i-gel - a line marking the optimal position for the teeth to sit if inserted correctly.

Sponsors

Ambulance Service of New South Wales
Lead SponsorGovernment body

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
No

Inclusion criteria

Out-of-hospital cardiopulmonary arrest attended to by the Ambulance Service of New South Wales (ASNSW)

Exclusion criteria

Patient has been deceased for some time as evidenced by rigor mortis, dependent lividity or tissue decomposition. Injuries incompatible with life. Order by a doctor on scene. Refractory asystole.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026