Technical and Non-technical Training of Airway Management on ICUNCT01609829
iCOMtrain, Development and Evaluation of a Combined Training of Technical and Non-Technical Skills During the Management of Simulated Incidents in Intensive Care
An observational study of Technical and Non-technical Training of Airway Management on ICU, run by University of Zurich at 1 site in Switzerland.
Trial summary
The normal, the anticipated difficult and the unanticipated difficult airway are trained in the patient safety simulation center (University Hospital Zürich) and the training is being observed by video installation. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Technical and Non-technical Training of Airway Management on ICU
- What is being tested?
- SAFE (situation, all together, fly on, evaluate)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- 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 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Doctors and nurses working on the surcical ICU.
Who may be able to join
- doctors and nurses with a minimum of 12 moths of work experience.
Who cannot join
- staff members that deny participation or don't meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Bastian Grande, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital, Anesthesiology
Zurich, Canton of Zurich, 8091
About this study
The normal, the anticipated difficult and the unanticipated difficult airway are trained in the patient safety simulation center (University Hospital Zürich) and the training is being observed by video installation.
Step 1: normal airway (Phantom), technical training
Step 2: difficult airway (SimMan 3G), technical training
Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical and non-technical (CRM - crew resource management) training.
- Being tested
- SAFE (situation, all together, fly on, evaluate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE (situation, all together, fly on, evaluate)Procedure or surgery
Video-assisted, structured debriefing after simulated critical airway-events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Technical and Non-technical Training of Airway Management on ICUStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bastian Grande, MD, Principal investigator, University Childrens Hospital Zurich, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609829
- Sponsor's protocol ID
- iCOMtrain
- Status last verified
- May 2012
- First submitted
- 29 May 2012
- Last updated
- 1 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCOMtrain, Development and Evaluation of a Combined Training of Technical and Non-Technical Skills During the Management of Simulated Incidents in Intensive Care
- ClinicalTrials.gov ID
- NCT01609829
- Acronym / sponsor ID
- iCOMtrain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 1 Jun 2012 (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 normal, the anticipated difficult and the unanticipated difficult airway are trained in the patient safety simulation center (University Hospital Zürich) and the training is being observed by video installation.
Step 1: normal airway (Phantom), technical training
Step 2: difficult airway (SimMan 3G), technical training
Step 3: Simulation of normal and difficult airway management on ICU (SimMan 3G), technical and non-technical (CRM - crew resource management) training.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Doctors and nurses working on the surcical ICU.
Key inclusion criteria (1 listed)
- doctors and nurses with a minimum of 12 moths of work experience.
Key exclusion criteria (1 listed)
- staff members that deny participation or don't meet the inclusion criteria
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 |
|---|---|---|
| SAFE (situation, all together, fly on, evaluate)Video-assisted, structured debriefing after simulated critical airway-events. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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.
Bastian Grande, MD contact
Bastian Grande, MD principal investigator
University Childrens Hospital Zurich, Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Technical and Non-technical Training of Airway Management on ICU, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bastian Grande, MD (bastian.grande@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 1 Jun 2012.