Back to resultsI-Gel in Out-of-hospital Cardiac Arrest in Norway (I-CAN)
Primary Purpose
Out of Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
I-Gel
LTS, ETI or current airway management practice
Sponsored by
About this trial
This is an interventional treatment trial for Out of Hospital Cardiac Arrest
Eligibility 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.
Sites / Locations
- Haukeland University Hospital
- Innlandet Sykehus HF
- Helse Fonna HF
- Ambulanse Midt-Norge HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I-Gel
LTS, ETI or other airway practice
Arm Description
I-Gel supraglottic airway device
Laryngeal tube, endotracheal tube or other current airway management practice
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
survival to hospital discharge / 30-day survival
levels of ETCO2 related to the presence and quality of bystander CPR
cerebral function assessed by Glascow Outcome Score at discharge from hospital
insertion related complications
Full Information
NCT ID
NCT02090218
First Posted
January 29, 2014
Last Updated
June 27, 2016
Sponsor
Haukeland University Hospital
Collaborators
Sykehuset Innlandet HF, Helse Midt-Norge, Helse Fonna
1. Study Identification
Unique Protocol Identification Number
NCT02090218
Brief Title
I-Gel in Out-of-hospital Cardiac Arrest in Norway
Acronym
I-CAN
Official Title
I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Sykehuset Innlandet HF, Helse Midt-Norge, Helse Fonna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out of Hospital Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-Gel
Arm Type
Active Comparator
Arm Description
I-Gel supraglottic airway device
Arm Title
LTS, ETI or other airway practice
Arm Type
Active Comparator
Arm Description
Laryngeal tube, endotracheal tube or other current airway management practice
Intervention Type
Device
Intervention Name(s)
I-Gel
Intervention Description
I-Gel supraglottic airway device
Intervention Type
Device
Intervention Name(s)
LTS, ETI or current airway management practice
Intervention Description
Laryngeal tube, endotracheal tube, bag-mask-ventilation
Primary Outcome Measure Information:
Title
ventilation success
Description
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
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
survival to hospital discharge / 30-day survival
Time Frame
up to 30 days
Title
levels of ETCO2 related to the presence and quality of bystander CPR
Time Frame
up to 24 hours
Title
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
Title
insertion related complications
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir A Sunde, MD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon-Kenneth Heltne, MD, PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guttorm Brattebø, MD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanne Klausen, MD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Innlandet Sykehus HF
City
Brumunddal
ZIP/Postal Code
2381
Country
Norway
Facility Name
Helse Fonna HF
City
Haugesund
ZIP/Postal Code
5504
Country
Norway
Facility Name
Ambulanse Midt-Norge HF
City
Trondheim
ZIP/Postal Code
7502
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
I-Gel in Out-of-hospital Cardiac Arrest in Norway
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