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

Not Applicable
Terminated
Conditions
Out of Hospital Cardiac Arrest
Registration Number
NCT02090218
Lead Sponsor
Haukeland University Hospital
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 Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
550
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
ventilation successup 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
NameTimeMethod
survival to hospital discharge / 30-day survivalup to 30 days
insertion related complicationsup to 24 hours
cerebral function assessed by Glascow Outcome Score at discharge from hospitalparticipants will be followed for the duration of hospital stay, an expected average of 4 weeks
levels of ETCO2 related to the presence and quality of bystander CPRup to 24 hours

Trial Locations

Locations (4)

Haukeland University Hospital

🇳🇴

Bergen, Norway

Innlandet Sykehus HF

🇳🇴

Brumunddal, Norway

Helse Fonna HF

🇳🇴

Haugesund, Norway

Ambulanse Midt-Norge HF

🇳🇴

Trondheim, Norway

Haukeland University Hospital
🇳🇴Bergen, Norway

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