I-Gel in Out-of-hospital Cardiac Arrest in Norway

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02090218

Acronym

I-CAN

Enrollment

550

Registered

2014-03-18

Start date

2014-02-28

Completion date

2016-06-30

Last updated

2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out of Hospital Cardiac Arrest

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.

Interventions

DEVICEI-Gel

I-Gel supraglottic airway device

DEVICELTS, ETI or current airway management practice

Laryngeal tube, endotracheal tube, bag-mask-ventilation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
ventilation success	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

Measure	Time frame
survival to hospital discharge / 30-day survival	up to 30 days
levels of ETCO2 related to the presence and quality of bystander CPR	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
insertion related complications	up to 24 hours

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026