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

Not Applicable

Terminated

• Conditions: Out of Hospital Cardiac Arrest
• Interventions: Device: I-Gel; Device: LTS, ETI or current airway management practice

• 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

Study Timeline

• Study First Submitted: 2014-01-29
• Study Start: 2014-02
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

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

Arm && Interventions

Group	Intervention	Description
I-Gel	I-Gel	I-Gel supraglottic airway device
LTS, ETI or other airway practice	LTS, ETI or current airway management practice	Laryngeal tube, endotracheal tube or other current airway management practice

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
survival to hospital discharge / 30-day survival	up to 30 days
insertion related complications	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
levels of ETCO2 related to the presence and quality of bystander CPR	up to 24 hours

Trial Locations

Locations (4)

Ambulanse Midt-Norge HF; 🇳🇴 Trondheim, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Helse Fonna HF; 🇳🇴 Haugesund, Norway

Innlandet Sykehus HF; 🇳🇴 Brumunddal, Norway