Plain English Summary
Background and study aims
Gaining experience in awake fiberoptic intubation is difficult due to a lack of adequate training opportunities on difficult airways. The ORSIM is a virtual reality bronchoscopy simulator which contains multiple difficult airways and is being developed to address this problem.
The aim of our study is to evaluate if the ORSIM is a valid method to test anaesthesiologists fiberoptic intubation skills. We expect that more experienced participants need less time, rotations, distance, direction changes or impact to reach the goal of a successful intubation compared to more inexperienced participants or novices.
We also want to evaluate if there is a positive effect of deliberate practice with the ORSIM on anaesthesiologists fiberoptic intubation skills. We expect that with deliberate practice on the ORSIM, anaesthesiologists improve their skills compared to the group who isn't allowed to practice.
Who can participate?
Healthy volunteers who work within the AMC department of anaesthesia as anaesthesia residents, consultants or anaesthetic nurses
What does the study involve?
For the control group it involves performing procedures on the ORSIM at the start, after 6 and 12 months only. The intervention group has to perform the same procedures on the ORSIM at the start, after 6 and 12 months but they also had to practice every 6 weeks in between.
What are the possible benefits and risks of participating?
The benefits are improving personal skills through practice and there are no risks.
The study is run from a single center, university hospital and starts in May 2018 and is expected to run until July 2019. There is no funding needed for this study and the main contact is M. van Haperen, consultant anesthesist
Where is the study run from?
Academic Medical Centre Amsterdam (The Netherlands)
When is the study starting and how long is it expected to run for?
March 2018 to July 2019
Who is funding the study?
Academic Medical Centre Amsterdam (The Netherlands)
Who is the main contact?
Maartje van Haperen, firstname.lastname@example.org
Validation of the ORSIM simulator by randomizing healthy volunteers, consisting of anesthetic nurses, anesthetic residents and consultant anesthesiologists, between control or intervention group (participants practice on the ORSIM for 10 minutes every six weeks) as an assessment method of anesthetists intubation skills by flexible bronchoscopy, through comparing results generated by the ORSIM simulator based on participants’ level of experience and effect of training through comparing results of the participants in the intervention and control group
Gaining experience in awake fiberoptic intubation is difficult due to a lack of adequate training opportunities on difficult airways. Recently the ORSIM is a bronchoscopy simulator which contains multiple difficult airways is being developed. Within this study we want to evaluate if the ORSIM is a valid method to test anaesthesiologists fiberoptic intubatie skills. We expect that more experienced participants need less time, rotations, distance, direction changes or impact to reach the goal of a successful intubation compared to more inexperienced participants or novices.
We also want to evaluate if there is a positive effect of deliberate practice with the ORSIM on anaesthesiologists fiberoptic intubatie skills. We expect that with deliberate practice on the ORSIM, anaesthesiologists improve their skills compared to the group who isn't allowed to practice.
Approved 6/3/2018 METC (Medical Ethics Review Committee) of the Academical Medical Center (Meibergdreef 9, 1100DD, Amsterdam, The Netherlands; +31 20-5667389; email@example.com), ref: W18_068
Single center interventional randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Awake fiberoptic intubation
Participants consisting of three different levels of experience (expert, intermediate and novice) were all asked to perform the same procedures on the ORSIM after which they were randomised through lottery in either the control or intervention group. The intervention group was asked to practice every 6 weeks on the ORSIM during the whole study period of a year. Both groups were asked to perform the same procedures, partly different procedures compared to the first measurement to avoid learning by heart of the procedures, on the ORSIM at 6 months and 12 months time.
Primary outcome measure
1. Goals reached, duration, rotation, distance, direction changes and impact including an assessment of own skills as measured by the ORSIM simulator at baseline, 6 months and 12 months
2. Amount of flexible bronchoscopic intubations, using a visual analogue score (VAS) at baseline, 6 months and 12 months
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Anaesthesiology residents, consultant anaesthetist and anaesthetic nurses
Target number of participants
72 in total divided in 3 groups of 24 participants per group
Total final enrolment
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Academical Medical Centre (AMC)
Academisch Medisch Centrum
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Results and Publications
Publication and dissemination plan
Planned publication in a peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)