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

NCT ID: NCT02090218

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Out of Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I-Gel

I-Gel supraglottic airway device

Group Type ACTIVE_COMPARATOR

I-Gel

Intervention Type DEVICE

I-Gel supraglottic airway device

LTS, ETI or other airway practice

Laryngeal tube, endotracheal tube or other current airway management practice

Group Type ACTIVE_COMPARATOR

LTS, ETI or current airway management practice

Intervention Type DEVICE

Laryngeal tube, endotracheal tube, bag-mask-ventilation

Interventions

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I-Gel

I-Gel supraglottic airway device

Intervention Type DEVICE

LTS, ETI or current airway management practice

Laryngeal tube, endotracheal tube, bag-mask-ventilation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Helse Midt-Norge

OTHER

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geir A Sunde, MD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Jon-Kenneth Heltne, MD, PhD

Role: STUDY_CHAIR

Haukeland University Hospital

Guttorm Brattebø, MD

Role: STUDY_CHAIR

Haukeland University Hospital

Hanne Klausen, MD

Role: STUDY_DIRECTOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Innlandet Sykehus HF

Brumunddal, , Norway

Site Status

Helse Fonna HF

Haugesund, , Norway

Site Status

Ambulanse Midt-Norge HF

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2013/984/REK-Vest.

Identifier Type: -

Identifier Source: org_study_id

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