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I-Gel in Out-of-hospital Cardiac Arrest in Norway (I-CAN)

This study has been completed.
Sykehuset Innlandet HF
Helse Midt-Norge
Helse Fonna
Information provided by (Responsible Party):
Haukeland University Hospital Identifier:
First received: January 29, 2014
Last updated: June 27, 2016
Last verified: June 2016
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.

Condition Intervention
Out of Hospital Cardiac Arrest
Device: I-Gel
Device: LTS, ETI or current airway management practice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial

Resource links provided by NLM:

Further study details as provided by Haukeland University Hospital:

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

Enrollment: 550
Study Start Date: February 2014
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I-Gel
I-Gel supraglottic airway device
Device: I-Gel
I-Gel supraglottic airway device
Active Comparator: LTS, ETI or other airway practice
Laryngeal tube, endotracheal tube or other current airway management practice
Device: LTS, ETI or current airway management practice
Laryngeal tube, endotracheal tube, bag-mask-ventilation


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02090218

Haukeland University Hospital
Bergen, Norway, 5021
Innlandet Sykehus HF
Brumunddal, Norway, 2381
Helse Fonna HF
Haugesund, Norway, 5504
Ambulanse Midt-Norge HF
Trondheim, Norway, 7502
Sponsors and Collaborators
Haukeland University Hospital
Sykehuset Innlandet HF
Helse Midt-Norge
Helse Fonna
Principal Investigator: Geir A Sunde, MD Haukeland University Hospital
Study Chair: Jon-Kenneth Heltne, MD, PhD Haukeland University Hospital
Study Chair: Guttorm Brattebø, MD Haukeland University Hospital
Study Director: Hanne Klausen, MD Haukeland University Hospital
  More Information

Responsible Party: Haukeland University Hospital Identifier: NCT02090218     History of Changes
Other Study ID Numbers: 2013/984/REK-Vest.
Study First Received: January 29, 2014
Last Updated: June 27, 2016

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017