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

This study has been completed.
Sponsor:
Collaborators:
Sykehuset Innlandet HF
Helse Midt-Norge
Helse Fonna
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT02090218
First received: January 29, 2014
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • levels of ETCO2 related to the presence and quality of bystander CPR [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • insertion related complications [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090218

Locations
Norway
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
Investigators
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
ClinicalTrials.gov Identifier: NCT02090218     History of Changes
Other Study ID Numbers: 2013/984/REK-Vest. 
Study First Received: January 29, 2014
Last Updated: June 27, 2016
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016