Condition category
Respiratory
Date applied
01/07/2020
Date assigned
07/07/2020
Last edited
06/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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, m.vanhaperen@amsterdamumc.nl

Trial website

Contact information

Type

Public

Primary contact

Miss Maartje van Haperen

ORCID ID

http://orcid.org/0000-0002-0724-330X

Contact details

Academic Medical Centre
Department of Anaesthesia
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 626724900
m.vanhaperen@amsterdamumc.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

W18_068

Study information

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

Acronym

ORSIM study

Study hypothesis

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

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

Study design

Single center interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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

01/03/2018

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Anaesthesiology residents, consultant anaesthetist and anaesthetic nurses

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

72 in total divided in 3 groups of 24 participants per group

Total final enrolment

76

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/05/2018

Recruitment end date

01/07/2019

Locations

Countries of recruitment

Netherlands Antilles

Trial participating centre

Academical Medical Centre (AMC)
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center

Sponsor details

Department of Anesthesia
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20-5669111
b.preckel@amsterdamumc.nl

Sponsor type

Hospital/treatment centre

Website

https://www.amc.nl/web/Zorg.htm

Funders

Funder type

Hospital/treatment centre

Funder name

Academisch Medisch Centrum

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Netherlands

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

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/07/2020: Trial’s existence confirmed by Academical Medical Center Amsterdam.