Validation of the ORSIM simulator as an assessment method of anesthetists skills at placing a breathing tube in patients (intubation)
| ISRCTN | ISRCTN35432230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35432230 |
| Secondary identifying numbers | W18_068 |
- Submission date
- 01/07/2020
- Registration date
- 07/07/2020
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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, m.vanhaperen@amsterdamumc.nl
Contact information
Public
Academic Medical Centre
Department of Anaesthesia
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
 ORCID ID |
0000-0002-0724-330X |
|---|---|
| Phone | +31 626724900 |
| m.vanhaperen@amsterdamumc.nl |
Study information
| Study design | Single center interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | 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 |
| Study acronym | ORSIM study |
| Study objectives | 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. |
| Ethics approval(s) | Approved 6/3/2018 METC (Medical Ethics Review Committee) of the Academical Medical Center (Meibergdreef 9, 1100DD, Amsterdam, The Netherlands; +31 20-5667389; mecamc@amc.uva.nl), ref: W18_068 |
| Health condition(s) or problem(s) studied | Awake fiberoptic intubation |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| 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 study start date | 01/03/2018 |
| Completion date | 31/07/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 72 in total divided in 3 groups of 24 participants per group |
| Total final enrolment | 76 |
| Key inclusion criteria | Anaesthesiology residents, consultant anaesthetist and anaesthetic nurses |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 01/07/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1105 AZ
Netherlands
Sponsor information
Hospital/treatment centre
Department of Anesthesia
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20-5669111 |
|---|---|
| b.preckel@amsterdamumc.nl | |
| Website | https://www.amc.nl/web/Zorg.htm |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 14/02/2018 | 13/09/2022 | No | No |
| Results article | 09/08/2023 | 06/08/2024 | Yes | No |
Additional files
Editorial Notes
06/08/2024: Publication reference added.
13/09/2022: Uploaded protocol (not peer reviewed).
11/08/2022: The intention to publish date has been changed from 01/12/2021 to 01/12/2023.
16/06/2021: The intention to publish date has been changed from 01/12/2020 to 01/12/2021.
06/07/2020: Trial’s existence confirmed by Academical Medical Center Amsterdam.
