Clinical Trial: I-Gel in Out-of-hospital Cardiac Arrest in Norway

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Haukeland University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: January 29, 2014
Date Started: February 2014
Date Completion:
Last Updated: June 27, 2016
Last Verified: June 2016