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

Out of Hospital Cardiac Arrest Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02090218
• Other study ID #: 2013/984/REK-Vest.
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 550
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• I-Gel
I-Gel supraglottic airway device
• LTS, ETI or current airway management practice
Laryngeal tube, endotracheal tube, bag-mask-ventilation

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Innlandet Sykehus HF	Brumunddal
Norway	Helse Fonna HF	Haugesund
Norway	Ambulanse Midt-Norge HF	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Fonna, Helse Midt-Norge, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	survival to hospital discharge / 30-day survival		up to 30 days
Secondary	levels of ETCO2 related to the presence and quality of bystander CPR		up to 24 hours
Secondary	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
Secondary	insertion related complications		up to 24 hours