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

NCT02090218 | Terminated

• 1 other identifier: 2013/984/REK-Vest.
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 4

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.

Conditions

Out of Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

I-Gel

ACTIVE COMPARATOR

I-Gel supraglottic airway device

Device: I-Gel

LTS, ETI or other airway practice

ACTIVE COMPARATOR

Laryngeal tube, endotracheal tube or other current airway management practice

Device: LTS, ETI or current airway management practice

Interventions

I-Gel DEVICE

I-Gel supraglottic airway device

I-Gel

LTS, ETI or current airway management practice DEVICE

Laryngeal tube, endotracheal tube, bag-mask-ventilation

LTS, ETI or other airway practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Non-adult patients / minors (\< 18 years).
• Traumatic cardiac arrest.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Sykehuset Innlandet HF: collaborator
• Helse Midt-Norge: collaborator
• Helse Fonna: collaborator

Study Sites (4)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Innlandet Sykehus HF

Brumunddal, 2381, Norway

Location

Helse Fonna HF

Haugesund, 5504, Norway

Location

Ambulanse Midt-Norge HF

Trondheim, 7502, Norway

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Geir A Sunde, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Jon-Kenneth Heltne, MD, PhD

  Haukeland University Hospital

  STUDY CHAIR

• Guttorm Brattebø, MD

  Haukeland University Hospital

  STUDY CHAIR

• Hanne Klausen, MD

  Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: March 18, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 9, 2024

Record last verified: 2016-06

Locations

NO (4)