I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial

Haukeland University Hospital4 sites in 1 country550 target enrollmentFebruary 2014

ConditionsOut of Hospital Cardiac Arrest

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Out of Hospital Cardiac Arrest
Sponsor: Haukeland University Hospital
Enrollment: 550
Locations: 4
Primary Endpoint: ventilation success
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this trial is to compare the effectiveness of a newer supraglottic airway method (the i-Gel), compared to current airway management practice in out-of-hospital cardiac arrests treated by Norwegian ambulance services.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

June 2016

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Haukeland University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Out-of-hospital cardiac arrest patients requiring and receiving advanced airway management on ambulance missions. Advanced airway management is defined as the attempted insertion of an airway adjunct (I-Gel, laryngeal tube or ETI) or the administration of ventilatory assistance/support (including bag-mask ventilation (BMV) or other ventilatory support.
•Adult patients (\> 18 years).

Exclusion Criteria

•Non-adult patients / minors (\< 18 years).
•Traumatic cardiac arrest.

Outcomes

Primary Outcomes

ventilation success

Time Frame: up to 24 hours

ventilation success defined as successful insertion of device with visible chest movement with each ventilation, audible air passage on auscultation, and ETCO2 confirmation (if available) of tube placement

Secondary Outcomes

survival to hospital discharge / 30-day survival(up to 30 days)
insertion related complications(up to 24 hours)
cerebral function assessed by Glascow Outcome Score at discharge from hospital(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
levels of ETCO2 related to the presence and quality of bystander CPR(up to 24 hours)