Out of Hospital Cardiac ArrestI-CANNCT02090218
I-Gel in Out-of-hospital Cardiac Arrest in Norway
A study testing I-Gel and LTS, ETI or current airway management practice in people with Out of Hospital Cardiac Arrest, run by Haukeland University Hospital at 4 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest
- What is being tested?
- I-Gel and LTS, ETI or current airway management practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 4 sitesNorway
- Study dates
- Feb 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Non-adult patients / minors (< 18 years).
- Traumatic cardiac arrest.
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland University Hospital
Bergen, 5021
Innlandet Sykehus HF
Brumunddal, 2381
Helse Fonna HF
Haugesund, 5504
Ambulanse Midt-Norge HF
Trondheim, 7502
About this study
Official title: I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial
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
- Being tested
- I-Gel, LTS, ETI or current airway management practice
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-GelDevice
I-Gel supraglottic airway device
LTS, ETI or current airway management practiceDevice
Laryngeal tube, endotracheal tube, bag-mask-ventilation
| Study group | Role | What they receive |
|---|---|---|
| I-Gel | Active comparator | I-Gel supraglottic airway device Receives: Device: I-Gel |
| LTS, ETI or other airway practice | Active comparator | Laryngeal tube, endotracheal tube or other current airway management practice Receives: Device: LTS, ETI or current airway management practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 hours
Secondary outcomes (4)
survival to hospital discharge / 30-day survival
Measured: up to 30 days
levels of ETCO2 related to the presence and quality of bystander CPR
Measured: up to 24 hours
cerebral function assessed by Glascow Outcome Score at discharge from hospital
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
insertion related complications
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Lack of patients/centres included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Helse Midt-Norge, Helse Fonna
- Responsible party
- Sponsor
- Investigators
- Geir A Sunde, MD, Principal investigator, Haukeland University HospitalJon-Kenneth Heltne, MD, PhD, Study chair, Haukeland University HospitalGuttorm Brattebø, MD, Study chair, Haukeland University HospitalHanne Klausen, MD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090218
- Sponsor's protocol ID
- 2013/984/REK-Vest.
- Acronym
- I-CAN
- Status last verified
- Jun 2016
- First submitted
- 29 Jan 2014
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial
- ClinicalTrials.gov ID
- NCT02090218
- Acronym / sponsor ID
- I-CAN / 2013/984/REK-Vest.
- Conditions
- Out of Hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients/centres included.
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Helse Midt-Norge, Helse Fonna
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-Gel | Active comparator | Device: I-GelI-Gel supraglottic airway device |
| LTS, ETI or other airway practice | Active comparator | Device: LTS, ETI or current airway management practiceLaryngeal tube, endotracheal tube or other current airway management practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Non-adult patients / minors (< 18 years).
- Traumatic cardiac arrest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-GelI-Gel supraglottic airway device | Device | I-Gel |
| LTS, ETI or current airway management practiceLaryngeal tube, endotracheal tube, bag-mask-ventilation | Device | LTS, ETI or other airway practice |
Primary outcome
ventilation success
Time frame: 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
4 secondary outcomes
survival to hospital discharge / 30-day survival
Time frame: up to 30 days
levels of ETCO2 related to the presence and quality of bystander CPR
Time frame: up to 24 hours
cerebral function assessed by Glascow Outcome Score at discharge from hospital
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
insertion related complications
Time frame: up to 24 hours
Results and safety
The study was stopped early (reason given: Lack of patients/centres included.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir A Sunde, MD principal investigator
Haukeland University Hospital
Jon-Kenneth Heltne, MD, PhD study chair
Haukeland University Hospital
Guttorm Brattebø, MD study chair
Haukeland University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-Gel and LTS, ETI or current airway management practice in people with Out of Hospital Cardiac Arrest, run by Haukeland University Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of patients/centres included.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilation success (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.