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Trial registered on ANZCTR


Registration number
ACTRN12610000472077
Ethics application status
Approved
Date submitted
7/06/2010
Date registered
9/06/2010
Date last updated
8/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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?
Secondary ID [1] 251906 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiopulmonary arrest 257296 0
Condition category
Condition code
Cardiovascular 257446 257446 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256429 0
Treatment: Devices
Comparator / control treatment
The Smiths Soft Seal Laryngeal Mask Airway (LMA) consists of a thin plastic inflatable cuff, which is designed to create a seal of the laryngeal, pharyngeal and perilaryngeal structures. The connecting soft flexible plastic tube performs as a way in which to administer oxygen to the patient in cardiac arrest. It has no integrated bite block, so a bite block is supplied to insert with the device.

The patient will have the LMA 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 should sit in the oesophageal opening and the aperture of the cuff sits over the the tracheal opening, however there is no epiglottis blocker so there is also a higher risk of the aperture being blocked by the epiglottis.
Control group
Active

Outcomes
Primary outcome [1] 258369 0
Rise and fall of chest with each bag ventilation visually examined by paramedics
Timepoint [1] 258369 0
Immediately after insertion of the artificial airway and during ventilation following each time the patient is moved for up to 10 seconds
Primary outcome [2] 258370 0
Bilateral breath sounds in axilla auscultated using stethoscope by paramedics
Timepoint [2] 258370 0
Immediately after insertion of the artificial airway and during ventilation for up to 10 seconds
Primary outcome [3] 258371 0
Colour change in the CO2 (carbon dioxide) detector from purple to yellow
Timepoint [3] 258371 0
After insertion of the artificial airway and then supplying six breaths to the patient
Secondary outcome [1] 264101 0
Return of spontaneous circulation, confirmed by palpable pulse detected by paramedic
Timepoint [1] 264101 0
On arrival at hospital
Secondary outcome [2] 264102 0
Ease of insertion of the device, rated by paramedic using numerical rating scale (NRS)
Timepoint [2] 264102 0
After insertion

Eligibility
Key inclusion criteria
Out-of-hospital cardiopulmonary arrest attended to by the Ambulance Service of New South Wales (ASNSW)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2875 0
2065
Recruitment postcode(s) [2] 2876 0
2076
Recruitment postcode(s) [3] 2877 0
2170
Recruitment postcode(s) [4] 2878 0
2021

Funding & Sponsors
Funding source category [1] 256920 0
Commercial sector/Industry
Name [1] 256920 0
Mayo Healthcare Australia
Country [1] 256920 0
Australia
Primary sponsor type
Government body
Name
Ambulance Service of New South Wales
Address
Ambulance State Headquarters
Balmain Road
Rozelle
NSW 2039
Country
Australia
Secondary sponsor category [1] 256189 0
None
Name [1] 256189 0
Address [1] 256189 0
Country [1] 256189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258926 0
Sydney South West Area Health Service Ethics Review Committe (Royal Prince Alfred Hospital Zone)
Ethics committee address [1] 258926 0
Research Development Office
Level 3, Building 92
John Hopkins Drive
Royal Prince Alfred Hospital
Camperdown
NSW 2050
Ethics committee country [1] 258926 0
Australia
Date submitted for ethics approval [1] 258926 0
06/01/2010
Approval date [1] 258926 0
28/01/2010
Ethics approval number [1] 258926 0
X09-0348

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31130 0
Address 31130 0
Country 31130 0
Phone 31130 0
Fax 31130 0
Email 31130 0
Contact person for public queries
Name 14377 0
Ric Thomas
Address 14377 0
Building 127
Church Street
Lilyfield
NSW 2039
Country 14377 0
Australia
Phone 14377 0
+61 2 97793854
Fax 14377 0
Email 14377 0
[email protected]
Contact person for scientific queries
Name 5305 0
Ric Thomas
Address 5305 0
Building 127
Church Street
Lilyfield
NSW 2039
Country 5305 0
Australia
Phone 5305 0
+61 2 97793854
Fax 5305 0
Email 5305 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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