I-CAN: I-Gel in Out-of-hospital Cardiac Arrest in Norway

Sponsor

Haukeland University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02090218

Collaborator

Sykehuset Innlandet HF (Other), Helse Midt-Norge (Other), Helse Fonna (Other)

550

Enrollment

Locations

Arms

Duration (Months)

137.5

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Out of Hospital Cardiac Arrest	Device: I-Gel Device: LTS, ETI or current airway management practice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

550 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

ventilation success [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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Haukeland University Hospital	Bergen	Norway	5021
2	Innlandet Sykehus HF	Brumunddal	Norway	2381
3	Helse Fonna HF	Haugesund	Norway	5504
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT02090218

Other Study ID Numbers:

2013/984/REK-Vest.

First Posted:

Mar 18, 2014

Last Update Posted:

Jun 28, 2016

Last Verified:

Jun 1, 2016

Additional relevant MeSH terms:

Heart Arrest

Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of Jun 28, 2016