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

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

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.

Study Overview

• Status: Terminated
• Conditions: Out of Hospital Cardiac Arrest
• Intervention / Treatment: Device: I-Gel; Device: LTS, ETI or current airway management practice

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Brumunddal, Norway, 2381
    • Innlandet Sykehus HF
  • Haugesund, Norway, 5504
    • Helse Fonna HF
  • Trondheim, Norway, 7502
    • Ambulanse Midt-Norge HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilation success	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	up to 24 hours

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Sykehuset Innlandet HF; Helse Fonna; Helse Midt-Norge
• 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

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimated): March 18, 2014

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2013/984/REK-Vest.